Order Code RL31263
Report for Congress
Received through the CRS Web
Bioterrorism: Legislation to Improve Public Health
Preparedness and Response Capacity
Updated May 8, 2002
C. Stephen Redhead
Donna U. Vogt
Domestic Social Policy Division
Mary E. Tiemann
Resources, Science, & Industry Division
Congressional Research Service ˜ The Library of Congress

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Bioterrorism: Legislation to Improve Public Health
Preparedness and Response Capacity
Summary
The recent anthrax attacks, though small in scale compared to the scenarios envisioned
by bioterrorism experts, strained the public health system and raised concern that the nation
is insufficiently prepared to respond to bioterrorist attacks. Improving public health
preparedness and response capacity offers protection not only from bioterrorist attacks, but
also from naturally occurring public health emergencies.
In December 2001, the House and Senate each passed legislation (H.R. 3448, S.
1765) to improve the public health system’s capacity to respond to bioterrorism. This
legislation builds on the programs and authorities established in Title III of the Public Health
Service (PHS) Act by the Public Health Threats and Emergencies Act of 2000 (P.L. 106-
505, Title I). While the two bills are similar in many respects, there are several key
differences that are being addressed in conference.
The Senate bill (S. 1765) would authorize a total of $3.25 billion in FY2002 to
increase the public health system’s bioterrorism preparedness and response capability,
including $640 million to expand the National Pharmaceutical Stockpile (NPS), $509 million
to purchase smallpox vaccine, and $1.46 billion for grants to state and local health
departments and hospitals. S. 1765 would also strengthen regulation of domestic and
imported food by the Food and Drug Administration (FDA) and give the U.S. Department
of Agriculture (USDA) new authority to safeguard the nation’s agricultural industry from the
threat of bioterrorism.
The House bill (H.R. 3448) would authorize almost $3 billion in FY2002 for
bioterrorism preparedness, including $646 million to expand the NPS, $509 million to
purchase smallpox vaccine, and $1 billion for grants to states and localities. H.R. 3448 does
not include any of the agricultural provisions that appear in S. 1765. Unlike the Senate bill,
however, H.R. 3448 includes provisions to protect community drinking water supplies from
bioterrorism and it places more emphasis on upgrading facilities at the Centers for Disease
Control and Prevention (CDC).
While lawmakers work towards final passage of new authorizing legislation, Congress
has appropriated $3 billion to the Dept. of Health and Human Services (HHS) for FY2002
to increase bioterrorism preparedness at the federal, state, and local levels. HHS anti-
bioterrorism funding was included in the FY2002 Labor-HHS-Education appropriations bill
(P.L. 107-116, H.R. 3061) and in the $20 billion emergency spending package (P.L. 107-
117, H.R. 3338). HHS is dispersing the funds according to existing authorities and the
broad spending parameters set out in the appropriations bills.
The following analysts may be contacted for additional information:
Stephen Redhead (7-2261)
HHS/CDC programs and policies
& Pamela Smith (7-7048)
Donna Vogt (7-7285)
Food safety (FDA)
Jean Rawson (7-7283)
Agriculture safety and security (USDA)
Mary Tiemann (7-5937)
Drinking water safety and security

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
House and Senate Bioterrorism Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Bioterrorism Preparedness Act (S. 1765) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Public Health Security and Bioterrorism Response Act (H.R. 3448) . . . . . . . . . . 3
Appendix A. HHS Bioterrorism Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
FY1999–FY2001 Bioterrorism Initiative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
FY2002 Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Labor-HHS-Education Appropriations . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Emergency Supplemental Appropriations . . . . . . . . . . . . . . . . . . . . . . . . . 30
FY2003 Budget Request . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Appendix B. CDC and HRSA Bioterrorism Preparedness Grant Programs . . . . . . . . 34
State and Local Public Health Department Preparedness . . . . . . . . . . . . . . . . . . 34
Hospital Preparedness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Coordination and Review of State Work Plans . . . . . . . . . . . . . . . . . . . . . . . . . 34
Appendix C. Bioterrorism-Related Hearings
(107th Congress) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Appendix D. Bioterrorism-Related Web Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Department of Health and Human Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Department of Defense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
State and Local Health Departments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Professional Associations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Academic Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
List of Tables
Table 1. Side-by-Side Comparison of Legislation on Public Health Preparedness for
Bioterrorism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Table 2. HHS Bioterrorism Funding ($ millions) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

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Bioterrorism: Legislation to Improve
Public Health Preparedness and
Response Capacity
Introduction
The September 11, 2001 terrorist attacks and the subsequent deliberate release of
anthrax spores in the mail have focused policymakers’ attention on the preparedness and
response capability of the U.S. public health system. Though small in scale compared to
the scenarios envisioned by bioterrorism experts and played out in recent government
exercises, the recent anthrax attacks strained the public health system and exposed
weaknesses at the federal, state, and local levels. Many bioterrorism experts believe that
had those responsible for the anthrax attacks employed a more sophisticated delivery
mechanism or released a deadly communicable biological agent such as smallpox, the
health care system may have been overwhelmed.
Bioterrorism poses a unique challenge to the medical care and public health systems.
Unlike an explosion or chemical attack, which results in immediate and visible casualties,
the public health impact of a biological attack can unfold gradually over time. Until a
sufficient number of people arrive at emergency rooms and doctors’ offices complaining
of similar illnesses, there may be no sign that an attack has taken place. The speed and
accuracy with which doctors and laboratories reach the correct diagnoses and report their
findings to public health authorities has a direct impact on the number of people who
become ill and the number that die. The nation’s ability to respond to a bioterrorist attack,
therefore, depends crucially on the state of preparedness of its medical care systems and
public health infrastructure.
Public health experts have for years complained about the deterioration of the public
health system through neglect and lack of funding. They warn that the nation is ill-equipped
and insufficiently prepared to respond to a bioterrorist attack. For example, they point out
that there are too few medical personnel trained to spot biological attacks, a shortage of
sophisticated laboratories to identify the agents, and inadequate supplies of drugs and
vaccines to counteract the threat. They also contend that inadequate plans exist for setting
up quarantines and emergency facilities to handle the sick and infectious victims. Improving
public health preparedness and response capacity offers protection not only from
bioterrorist attacks, but also from naturally occurring public health emergencies. Public
health officials are increasingly concerned about our exposure and susceptibility to
infectious disease and food-borne illness because of global travel, ubiquitous food imports,
and the evolution of antibiotic-resistant pathogens.
In December 2001, the House and Senate each passed comprehensive bioterrorism
preparedness legislation (H.R. 3448, S. 1765) with broad bipartisan support. This report

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CRS-2
summarizes H.R. 3448 and S. 1765 and provides a side-by-side comparison of the
provisions in each bill and in current law. Lawmakers also appropriated $3 billion to the
Dept. of Health and Human Services (HHS) for FY2002 to improve bioterrorism
preparedness. Anti-bioterrorism funding was provided in the FY2002 Labor-HHS-
Education appropriations bill (P.L. 107-116, H.R. 3061) and in the anti-terrorism
emergency supplemental appropriations bill (P.L. 107-117, H.R. 3338). Details of HHS’s
bioterrorism funding, including the Administration’s FY2003 budget request, are provided
in Appendix A. Appendix B provides information on the HHS grant programs to improve
public health and hospital preparedness. Appendix C lists all the bioterrorism-related
hearings in the 107th Congress. In most cases, hearing testimony is available on the
committee Web sites. Finally, Appendix D provides a list of bioterrorism-related Web
sites.
For a discussion of bioterrorism preparedness issues, see CRS Report RL31225,
Bioterrorism: Summary of a CRS/National Health Policy Forum Seminar on Federal,
State, and Local Public Health Preparedness.
House and Senate Bioterrorism Legislation
Bioterrorism Preparedness Act (S. 1765)
Senators Frist and Kennedy introduced the Bioterrorism Preparedness Act (S. 1715)
on November 15, 2001. In a procedural move aimed at bypassing committee
consideration and allowing prompt floor consideration, the legislation’s sponsors
reintroduced the bill (S. 1765) with 74 cosponsors on December 4, 2001. On December
20, 2001, the Senate took up the House bioterrorism bill (H.R. 3448, see below),
substituted the text of S. 1765, and passed H.R. 3448, as amended.
The Bioterrorism Preparedness Act builds on the programs and authorities
established in Title III of the Public Health Service (PHS) Act by the Public Health Threats
and Emergencies Act of 2000 (P.L. 106-505, Title I). S. 1765 incorporates ideas and
objectives from a number of other Senate bioterrorism bills introduced in the wake of the
anthrax attacks.1 It is intended to improve the health system’s capacity to respond to
1 Senate bioterrorism preparedness bills introduced in response to the September 11 attacks
and the anthrax incidents include: the Biological and Chemical Weapons Preparedness Act
of 2001 (S. 1486) introduced by Senator Edwards on Oct. 3, 2001; the Biological and
Chemical Attack Preparedness Act (S. 1508) introduced by Senator Corzine on Oct. 4, 2001;
the State Bioterrorism Preparedness Act (S. 1520) introduced by Senator Bayh on Oct. 9,
2001; the Protecting America’s Children Against Terrorism Act (S. 1539) introduced by
Senator Clinton on Oct. 11, 2001; the Bioterrorism Awareness Act (S. 1548) introduced by
Senator Carnahan on Oct. 15, 2001; the Protecting the Food Supply from Bioterrorism Act
(S. 1551) introduced by Senator Clinton on Oct. 15, 2001; the Agricultural Bioterrorism
Countermeasures Act of 2001 (S. 1563) introduced by Senator Hutchison on Oct. 17, 2001;
the Public Health Emergency Planning and Information Act of 2001 (S. 1574) introduced by
Senator Rockefeller on Oct. 25, 2001; the Pathogen Research, Emergency Preparedness and
Response Efforts (PREPARE) Act of 2001 (S. 1635) introduced by Senator Hutchinson on
(continued...)

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CRS-3
bioterrorism, protect the nation’s food supply from bioterrorist attacks, speed the
development and production of new drug treatments and vaccines, improve coordination
of federal anti-bioterrorism activities, and increase investment in state and local
preparedness. S. 1765 is a 5-year authorization bill, which calls for a total of $3.25 billion
in funding for FY2002 and such sums as may be necessary for the remaining years. Key
provisions of the bill are summarized in the text box below, including the authorized
appropriations for FY2002 (in parentheses).
Bioterrorism Preparedness Act of 2001 (S. 1765)
I. Federal Bioterrorism Preparedness and Response Capability:
! Expand the National Pharmaceutical Stockpile ($640 million).
! Upgrade CDC’s bioterrorism response capability ($60 million).
! Improve public health laboratories ($59.5 million).
! Tighten controls on the possession and use of biological agents and
toxins.
II. State and Local Bioterrorism Preparedness and Response Capability:
! Authorize block grants to states ($667 million).
! Expand existing discretionary grant programs ($420 million).
! Authorize grants to improve hospital response capability ($370 million).
III. Anti-Bioterrorism Drugs and Vaccines:
! Purchase smallpox vaccine ($509 million).
! Authorize long-term contracts for vaccine and drug development and
provide limited exemption from federal antitrust laws.
IV. Food Supply and Agriculture ($525.5 million):
! Strengthen FDA regulation of domestic and imported food.
! Expand and upgrade the safety and security of the nation’s food
supply, livestock, and crops.
Public Health Security and Bioterrorism Response Act (H.R.
3448)
Representatives Tauzin (R-LA) and Dingell (D-MI) introduced the Public Health
Security and Bioterrorism Response Act (H.R. 3448) on December 11, 2001. The bill
was immediately considered under suspension of the rules and passed by the House the
following day on a vote of 418–2 In many respects, H.R. 3448, which authorizes $3
billion in FY2002 to improve bioterrorism preparedness and response capacity, resembles
the Senate-passed bill. Both bills would authorize funds to expand the National
Pharmaceutical Stockpile, purchase smallpox vaccine, develop and produce anthrax
vaccine, and provide grants to state and local governments and public health departments.
However, there are a number of key differences between the House and Senate bills that
are being addressed in conference.
1 (...continued)
Nov. 6, 2001; and the Deadly Biological Agent Control Act of 2001 (S. 1661) introduced by
Senator Feinstein on Nov. 8, 2001.

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S. 1765 contains several provisions aimed at combating agricultural terrorism,
including one that would authorize the creation of a surveillance and response system to
detect biological threats to animals and plants. Another provision would authorize the
Secretary of Agriculture to award grants to universities to conduct research on improving
the security of facilities at which hazardous biological agents and toxins are stored for
agricultural research purposes. H.R. 3448 does not include any agricultural provisions.
The Senate bill also provides a limited exemption from federal antitrust law that would
enable drug companies to collaborate to develop vaccines. The House version has no
such provision.
H.R. 3448 includes a set of provisions aimed at protecting the nation’s drinking water
supply, which are not included in S. 1765. The House bill would authorize a total of $170
million in FY2002 to assess the vulnerability of community drinking water systems, help
communities develop emergency response plans, and take other steps to protect the water
supply from acts of terrorism. H.R. 3448 also contains language that would strengthen
FDA regulation of imported drugs, which is not present in S. 1765, and it places more
emphasis on upgrading CDC’s facilities and capacities. Key provisions of the House bill
are summarized in the text box below, including the authorized appropriations for FY2002
(in parentheses).
Public Health Security and Bioterrorism Response Act of 2001 (H.R. 3448)
I. Federal Bioterrorism Preparedness and Response Capacity:
! Expand the National Pharmaceutical Stockpile ($646 million).
! Upgrade CDC’s bioterrorism response capacity ($450 million).
! Tighten controls on the possession and use of biological agents and
toxins.
II. State and Local Bioterrorism Preparedness and Response Capacity:
! Expand existing discretionary grant programs ($910 million).
! Relieve shortages of critical health care professionals ($40 million).
III. Anti-Bioterrorism Drugs and Vaccines:
! Purchase smallpox vaccine ($509 million).
! Stockpile potassium iodide near nuclear power plants.
IV. Food and Drug Supply:
! Strengthen FDA regulation of domestic and imported food ($100
million).
! Strengthen FDA regulation of imported drugs.
V. Drinking Water:
! Upgrade safety and security of drinking water supplies ($170 million).
Table 1 below provides a side-by-side comparison of H.R. 3448, S. 1765, and,
where applicable, current law. All the PHS Act Title III provisions relating to public health
emergencies that were established by P.L. 106-505 (i.e., Sections 319, 319A–319G) are
included in the table, regardless of whether they are amended by S. 1765 or H.R. 3448.

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Table 1. Side-by-Side Comparison of Legislation on Public Health Preparedness for Bioterrorism
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Establishing National Goals and Public Health Capacities, Assessing Public Health Needs
Establishing National Goals,
No statutory provisions.
Adds a new Title XXVIII to the Public Health
Adds a new Title XXVIII to the Public Health
Reports to Congress
Service (PHS) Act setting out the following
Service (PHS) Act that requires the Secretary,
national goals for bioterrorism preparedness: (i)
building on existing authority in PHS Act
provide federal assistance to states and localities
Section 319A, to develop and implement a
in the event of an attack; (ii) improve public
bioterrorism preparedness and response plan,
health preparedness and response; (iii) develop
in consultation with other federal agencies.
new vaccines and therapies; (iv) protect the food
The plan would coordinate the activities of
supply and agriculture. [Section 101]
state and local governments and meet the
prep aredness goals in the bill (e.g., effective
Adds a new Section 2811 to the PHS Act to
assistance to state and local governments,
require the Secretary to report to Congress
l a b o r a t o r y r e a d i n e s s , e f f e c t i v e
within 1 year, and biennially thereafter, on
communications networks, training, and
progress made toward meeting the objectives of
surveillance). Requires the Secretary to
the Act, including recommendations for new
evaluate the feasibility of utilizing the Dept.
legislative authority needed to protect public
of Veterans Affairs’ research capabilities.
health. Requires the Secretary to report to
Congress within 1 year on the vulnerability of
Similar reporting requirements to thos e in S.
rural communities to bioterrorism and
1765. [Section 101]
recommend any new legislative authority
needed to strengthen the preparedness of such
communities. [Section 201]
Establishing Public Health
Public Health Service (PHS) Act Section
No provisions.
No provisions.
Capacities
319A requires the Secretary, together with
state and local health officials, to establish
what capacities are needed for national, state,
and local public health systems to be able to
detect, diagnose, and contain outbreaks of
infectious disease, drug-resistant pathogens,
or acts of bioterrorism. Authorizes $4 million
for FY2001 and such sums as may be
necessary for FY2002– FY2006.

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Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Assessing Public Health Needs
PHS Act Section 319B auth o r i z e s g r a n t s t o
No provisions.
No provisions.
states and local public health departments to
evaluate the extent to which they can
achieve the capacities identified pursuant to
Section 319A. Requires the Secretary to
develop a national framework for the
evaluations. Authorizes $45 million for
FY2001, and such sums as may be necessary
for FY2002–FY2003.
Federal (HHS) Preparedness and Response Capacity
A s s i s t a n t S e c r e t a r y f o r
No statutory provisions.
Adds a new Section 2813 to the PHS Act
Adds a new Section 2811 to the PHS Act
Emergency Preparedness
aut horizing the appointment of an Assistant
authorizing the appointment of an Assistant
Secretary for Emergency Preparedness to head
Secretary for Emergency Preparedness to
the Office of Emergency Preparedness and
coordinate all HHS bioterrorism-related
coordinate all HHS bioterrorism activities.
activities under the Act and interface with
[Section 211]
other federal agencies. [Section 102]
Public Health Emergencies
PHS Act Section 319 a u t h o r i z e s t h e
Amends PHS Act Section 319 to require the
Amends PHS Act Section 319 as follows: (i)
Secretary to respond to public health
Secretary to notify Congress within 48 hours of
permits the Secretary during a public health
emergencies, including diseases, disorders,
declaring a public health emergency. Allows
emergency to transfer funds between
or bioterrorist attacks, by supporting grants,
such a declaration to remain in effect for 180
approp riations accounts administered under
contracts, and investigations. Establishes
days and permits the Secretary to extend that
this Act, without lengthy waiting periods,
the Public Health Emergency Fund and
p eriod, provided Congress is notified within 48
and requires the Secretary to notify Congress
authorizes such sums as may be necessary.
hours of the extension. Allows the Secretary, as
of the intent to make such a transfer; and (ii)
Requires an annual report to Congress on
a result of public health emergencies, to waive
provides that public health emergencies
expenditures from the Fund.
deadlines for the submission of data and reports
expire by announcement of the Secretary or
by individuals or public or private entities
after 90 days, whichever comes first, and
pursuant to any law administered by the
permits the Secretary to renew emergency
Secretary. [Section 212]
declarations.
Similar waiver authority to S. 1765. [Section
131, 134]

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CRS-7
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Quarantine and Inspection
PHS Act Section 361 authorizes the Surgeon
No provisions.
Amends PHS Act Secs. 361 and 363 by
General, in consultation with the Secretary,
eliminating the prerequisite for a National
t o d e v e l o p q u a r a n t i n e , i n s p e c t i o n ,
Advisory Health Council recommendation
f u m i g a t i o n , s a n i t a t i o n , a n d p e s t
before issuing a quarantine rule or a rule
extermination regulations to prevent the
p r o v i d i n g f o r t h e a p p r e h e n s i o n o f
introduction, transmission, or spread of
individuals during wartime. Permits federal
communicable diseases. Section 363
regulations under Secs. 361 & 363, as
authorizes the development of regulations
amended, to preempt state laws that conflict
for the apprehension and examination of
with the exercise of federal authority.
infected individuals in times of war.
[Section 132]
Federal Working Groups and
PHS Act Section 319F requires the Secretary
Amends PHS Act Section 319F by eliminating
Amends PHS Act Section 319F by
Advisory Committees
to: (i) establish, with the Secretary of
t he two existing working groups and replacing
e x p a n d i n g t h e c o m p o s i t i o n a n d
Defense, an interagency working group on
them with a single interagency working group
responsibilities of the two existing
bioterrorism preparedness, and (ii) establish,
on the prevention, preparedness, and response to
interagency working groups. Requires the
in collaboration with the Director of FEMA,
bioterrorism, to be established by the Secretary
Secretary to establish the preparedness
the Attorney General, and the Secretary of
in coordination with the Director of FEMA, the
w orking group in coordination with t h e
Agriculture, an interagency working group
Attorney General, and the Secretaries of
Director of FEMA, the Attorney General, the
to address the public health and medical
Agriculture, Defense, Labor, and Veterans
Secretaries of Agriculture, Defense, Energy,
consequences of a bioterrorist attack.
Affairs (VA), and with other federal officials as
and the VA, and the EPA Administrator.
appropriate. Creates two advisory committees to
Requires the Secretary to establish the public
the Secretary: (i) the National Task Force on
health and medical working group in
Children and Terrorism; and (ii) the Emergency
coordination with the Director of FEMA, the
Public Information and Communications Task
Attorney General, the Secretaries of
Force. Both Task Forces sunset after 1 year.
Agriculture, Defense, Labor, and the VA, and
[Section 213]
the EPA Administrator. Creates two advisory
committees to the Secretary: (i) the National
Advisory Committee on Children and
T errorism; and (ii) the Emergency Public
Information and Communications Advisory
Committee. Both committees sunset after 1
year. Requires a coordinated strategy on
public health communications during a
bioterrorist attack. [Section 104, 108]

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CRS-8
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
N a t i o n a l D i s a s t e r M e d i c a l
No statutory provisions. The NDMS was
Adds a new Section 2814 to the PHS Act
Adds a new Section 2811 to the PHS Act
System (NDMS)
established in 1984 as a partnership of four
providing statutory authorization for the NDMS,
containing similar provisions to S. 1765, but
federal agencies (HHS, FEMA, DOD, VA),
to be coordinated by the Secretary in
with the following additional requirements
state and local governments, and the private
collaboration with FEMA, DOD, and the VA.
and authorizations: requires the Secretary to
sector to provide medical assistance and
Appoints activated NDMS volunteers as
collaborate with states and other public and
hospitalization for mass casualties in the
temporary federal employees and establishes
private entities, and, within 1 year and
event of a natural or man-made disaster. It
employment and reemployment rights for
periodically thereafter, to conduct exercises
consists of more than 7,000 volunteer health
NDMS volunteers. [Section 211]
to test the capability and timeliness of the
professionals and support personnel. For
NDMS. Requires the Secretary to establish
m o r e i n f o r m a t i o n , g o t o
education and training criteria for NDMS
[http://ndms.dhhs.gov].
personnel. Authorizes such sums as may be
necessary for FY2002–FY2006 for NDMS
and to provide for the Assistant Secretary of
Emergency Preparedness. [Section 102]
N a t i o n a l P h a r m a c e u t i c a l
N o statutory provisions. The NPS, which
Adds a new Section 2812 to the PHS Act
Similar provisions to S. 1765, but with
Stockpile (NPS)
was established and is managed by the CDC,
requiring the Secretary, in coordination with the
additional requirements for periodic review
includes pharmaceuticals, vaccines, and
VA Secretary, to maintain a National
of the stockpile and the development of a
medical supplies that can be deployed
Pharmaceutical Stockpile of vaccines, drugs,
distribution plan. Requires the Secretary to
anywhere in the country in response to a
medical devices and supplies to meet the
consult with the Director of FEMA, the
public health emergency. For more
nation’s emergency public health needs.
Attorney General, the Secretaries of
information, go to [http://www.cdc.gov/
Authorizes $640 million for FY2002, and such
Agriculture, DOD, Energy , and the VA, the
nceh/nps/default.htm].
sums as may be necessary for FY2003–FY2006.
EPA Administrator, and state and local
[Section 201]
agencies. Authorizes $1.155 billion for
FY2002, of which $509 million is for
purchasing smallpox vaccine, and such sums
as may be necessary for FY2003–FY2006.
[Section 121, 151]
Upgrading CDC
PHS Act Section 319D authorizes funds for
Amends PHS Act Section 319D to clarify CDC’s
Amends PHS Act Section 319D to clarify
the construction and renovation of CDC
role in responding to bioterrorism. Authorizes
CDC’s role in responding to bioterrorism.
facilities, and to sup port the agency’s
$60 million for FY2002, and such sums as may
Requires the Secretary to upgrade CDC’s
activities to combat threats to public health.
be necessary for FY2003–FY2006, to upgrade
facilities and capacities. Provides
Authorizes $180 million for FY2001, and
CDC’s facilities and capacities. [Section 202]
authorization and multi-year contracting
such sums as may be necessary for
authority for renovation, development, and
FY2002–FY2010.
security at CDC facilities. Authorizes $450
million for FY2002, of which $300 million
is for upgrading facilities, $300 million for
FY2003 to upgrade facilities, and such sums
as may be necessary for FY2004–FY2006.
[Section 103, 151]

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CRS-9
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Public Health Laboratories
No statutory provisions. Over the past 3
Amends PHS Act Section 319D to provide
Amends PHS Act Section 319D to provide
Network, National Public Health
y ears, CDC has awarded grants to all 50
grants to establish a coordinated network of
grants to establish a coordinated network of
C o m m u n i c a t i o n s a n d
states and some metropolitan health
public health labs. Authorizes $59.5 million for
public health labs and to develop a national
Surveillance Network
departments to enhance state and local
FY2002, and such sums as may be necessary for
p u b l i c h e a l t h c o m m u n i c a t i o n s a n d
laboratory capacity and to help build an
FY2003–FY2006. [Section 202]
surveillance network. Authorizes such sums
national electronic communications network
as necessary for FY2002–FY2006. [Section
connecting all the components of the public
103]
health community. For more information, go
to [http://www.bt.cdc.gov].
Requires that all the FY2003 and FY2004
infrastructure grants provided by the
N a t i o n a l T e l e c o m m u n i c a t i o n s a n d
Information Administration be awarded to
health providers to facilitate participation in
the national public health communications
and surveillance network. [Section 139]
Education and Training of
PHS Act 319F requires the Secretary to
Amends PHS Act Section 319F to require the
Amends PHS Act Section 319F by requiring
Health Care Personnel: Children
develop programs to educate health
interagency working group on the public health
the Secretary, in collaboration with the
a n d O t h e r V u l n e r a b l e
professionals in recognizing and caring for
and medical consequences of bioterrorism, in
interagency working group and professional
Populations
victims of bioterrorist attacks and programs
collaboration with professional organizations,
organizations, to award grants for the
to train laboratory personnel in identifying
to develop education programs that recognize
development of education materials to teach
bioweapons.
the special needs of children and other
health officials and other emergency
vulnerable populations during public health
personnel to identify potential bioweapons
emergencies. [Section 313; Note: The
and care for victims, recognizing the special
interagency working group to which this
needs of children and other vulnerable
subsection of the Act refers would be replaced
p o p u l a t i o n s d u r i n g p u b l i c h e a l t h
by two advisory committees under S. 1765, see
emergencies. [Section 105]
above.]
GAO Report
PHS Act 319F requires a GAO report t o
Amends PHS Act Section 319F to require a new
No provisions.
Congress, within 6 months, on federal
GAO report to Congress on federal bioterrorism-
bioterrorism-related activities, including
related activities, including the development of
research, preparedness, and response. [This
public health lab capacity. [Section 314]
report, GAO-01-915, was issued by GAO on
September 28, 2001.]

---

CRS-10
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Occupational Safety and Health
Section 22 of the Occupational Safety and
Amends OSH Act Section 22 to expand NIOSH
Requires the Secretary, acting through the
Health Act of 1970 (29 U.S.C. 671) created
research on bioterrorism threats and attacks in
Director of NIOSH, to expand research on
the National Institute for Occupational
the workplace. [Section 315]
bioterrorism threats and attacks in the
Safety and Health (NIOSH) as the federal
workplace. [Section 138]
agency responsible for conducting research
and making recommendations for the
prevention of work-related disease and
injury. NIOSH is part of the CDC.
Agency for Toxic Substances
ATSDR, an agency within HHS, was created
No provisions.
Requires the Secretary to integrate ATSDR
and Disease Registry (ATSDR)
by the Superfund legislation to investigate
into plans for bioterrorism preparedness and
and reduce the harmful effects of exposure to
response. Authorizes such sums as necessary
hazardous substances on human health.
f o r F Y 2 0 0 2 – F Y 2 0 0 6 f o r A T S D R ’ s
bioterrorism-related activities. [Section 137]
Federal Bioterrorism Web Site
No statutory provisions.
Recommends establishing a federal Web site on
No provisions.
bioterrorism with links to state and local
government sites. [Section 214]
Miscellaneous Provisions
No applicable provisions.
No provisions.
Requires the Secretary, in consultation with
other federal agencies, to conduct a study of
the ability of local public health entities to
maintain communications during a public
health emergency. [Section 111] Adds a
new Section 319J to the PHS Act allowing
the Secret ary to provide supplies, equipment,
or services instead of, or in conjunction with,
grants awarded under Sections 319 through
319I, or Section 319K. [Section 112]
Requires the Secretary to conduct a study of
best practices in local emergency response
and report to Congress within 180 days.
[Section 114]

---

CRS-11
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Medicare, Medicaid, and the State Children’s Health Insurance Program (SCHIP)
Emergency Waivers
Medicare covers medically necessary acute
No provisions.
Authorizes the Secretary to temporarily
care and follow-up services (hospital, short-
waive conditions of participation and other
term nursing home care, physician services,
certification requirements for any entity that
home health and a variety of outpatient
furnishes health care items or services to
services) for all persons age 65 and over, as
Medicare, Medicaid, or SCHIP beneficiaries
well as certain disabled persons. Medicaid
in an emergency area during a declared
covers acute and long-term care services for
disaster or public health emergency. In
low -income persons who are aged, blind,
addition, during such an emergency,
disabled, members of families with
authorizes the Secretary to waive: (i)
dependent children, and certain other
participation, state licensing (as long as
pregnant women and children. The State
equivalent licensure from another state is
Children’s Health Insurance Program
held), and pre-approval requirements for
(SCHIP) covers uninsured children living in
physicians and other practitioners; (ii)
families with income above applicable
sanctions for failing to meet requirements for
Medicaid standards, typically up to or above
emergency transfers between hospitals; and
200% of the federal poverty level. In all
(iii) sanctions for physician self-referral.
three programs, providers must meet certain
Requires the Secretary to provide Congress
standards in order to participate and receive
with a detailed written notice at least 2 days
reimbursement for services rendered to
prior to exercising this waiver authority.
program beneficiaries. For example,
Provides for the waiver authority to continue
hospitals and other facilities must meet
for 90 days. Permits the Secretary to extend
established conditions of participation, and
the waiver period. Requires the Secretary,
laboratories must be certified under the
within 1 year after the end of the emergency,
Clinical Laboratories Improvement Act
to provide Congress with an evaluation of
(CLIA). Physicians must be licensed to
t h e s u c c e s s o f t h i s a p p r o a c h a n d
provide medical services in the state where
recommendations for improvements under
medical care is rendered, and must follow
this waiver authority. [Section 133]
established rules for obtaining prior approval
to deliver certain types of services. Also,
physicians must not refer patients to medical
entities with which they have a financial
relationship. Other statutory provisions
require hospitals to fully stabilize patients
receiving emergency care prior to transfer to
another medical facility.

---

CRS-12
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Regulation of Biological Agents and Toxins
Use and Possession of Select
The 1996 Antiterrorism and Effective Death
Codifies and expands provisions of P.L. 104-
Similar provisions to S. 1765, but with added
Agents
Penalty Act (P.L. 104-132, Section 511)
132 in the PHS Act under a new Section 351A.
security provisions: (i) requires the Secretary
required the Secretary to establish a list of
Requires the Secretary to: (i) establish and, at
to consult with the Attorney General in
biological agents that could pose a severe
least biennially, review and, if necessary, revise
establishing security requirements for
threat to public health and safety, and
a list of biological agents and toxins that could
persons possessing, using, or transferring
establish safety procedures for transferring
pose a severe threat to public health and safety;
listed agents or toxins; and (ii) requires the
listed agents and toxins so as to protect
(ii) establish safety procedures for transferring
Secretary, in consultation with the Attorney
public safety and prevent access by terrorists
listed agents and toxins so as to protect public
General and other federal agencies, to
(see 42 C.F.R. 72).
safety and prevent access by terrorists; (iii)
establish a screening protocol to ensure that
establish standards and procedures for the
access to such agents and toxins is not
possession and use of listed agents and toxins so
permitted by certain sp ecified types of
as to protect public health and safety; and (iv)
individuals (e.g., those with criminal records,
require registration for the possession, use, and
suspected terrorists, etc.). Requires the
transfer of listed agents and toxins and maintain
S e c r e t a r y t o c o o r d i n a t e r e g u l a t i o n s
a national database of the location of such
promulgated under these provisions with
agents and toxins. Requires the Secretary to
Dept. of Agriculture regulations governing
establish security requirements for persons
use of biological agents in developing
possessing, using, or transferring listed agent s o r
animal vaccines and treatments. Clarifies
toxins, as a condition of registration.
that the Secretary’s new authorities do not
Authorizes the Secretary to conduct compliance
limit existing authorities of the Secretary of
inspections. Authorizes the Secretary to
Agriculture. Authorizes such sums as may be
establish exemptions from the requirements
necessary for FY2002, and each subsequent
outlined in (ii) and (iii) above that are consistent
fiscal year, to upgrade security at HHS
with protecting public health and safety,
facilities that contain listed agents and
including exemptions for the use of attenuated
toxins. [Section 201]
or inactive agents or toxins in research or for
medical purposes. Exempts clinical labs
presented with a listed agent or toxin for
diagnosis, verification, or proficiency testing.
Establishes civil penalties of up to $500,000
and criminal penalties of up to 5 years in prison
for those in violation of the above requirements
for the possession, use, and transfer of listed
agents and toxins. Protects information
collected under these regulations from
mandatory disclosure under the Freedom of
Information Act. Mandates a report to Congress
within 1 year. Repeals current law. [Section
216]

---

CRS-13
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
State and Local Preparedness and Response Capacity
B i o t e r r o r i s m P r e p a r e d n e s s
PHS Act Section 319F(c) authorizes grants to
Amends PHS Act Section 319F(c) by replacing
Amends PHS Act Section 319F(c) by
Grants to States and Local
states, localities, and health care facilities to
the existing grant program with block grants to
expanding the existing grant authorization
Public Health Agencies, and
increase their capacity to detect, diagnose,
states based on population, but with each state
to permit the use of funds for community-
Health Care Facilities
and respond to bioterrorist attacks , including
guaranteed a minimum level of funding.
wide planning activities, training, and
training of personnel. [Note: For all
Requires states to develop a detailed
purchasing or upgrading equipment,
activities under Section 319F, authorizes
bioterrorism preparedness plan to be eligible for
supplies, pharmaceuticals, and other
$215 million for FY2001, and such sums as
funding. Authorizes $667 million for FY2002,
countermeasures. Authorizes $455 million
may be necessary for FY2002–FY2006.]
and such sums as may be necessary for FY2003.
for FY2002, and such sums as may be
[Section 301]
necessary for FY2003–FY2006. [Section
108, 151]
Core Capacity Grants to State
PHS Act Section 319C authorizes grants to
Amends PHS Act Section 319C by authorizing
Amends PHS Act Section 319C by
a n d L o c a l P u b l i c H e a l t h
s tates and local governments, after they have
$420 million for FY2002, and such sums as may
expanding the existing grant authorization
Agencies
completed a Section 319B evaluation, to
be necessary for FY2003–FY2006. [Section
to permit the use of funds for purchasing or
address core public health capacity needs.
215]
u p g r a d i n g e q u i p m e n t , s u p p l i e s ,
Requires the Secretary to report to Congress
pharmaceuticals, and other countermeasures.
on activities carried out under Sections
Authorizes $455 million for FY2002, and
319A, 319B, and 319C by January 1, 2005.
such sums as may be necessary for
Authorizes $50 million for FY2001, and
FY2003–FY2006. [Section 109, 151]
such sums as may be necessary for
FY2002–FY2006.
Demonstration Grants
PHS Act Section 319G authorizes up to three
No provisions.
No provisions.
demonstration grants for up to 5 years to
states, localities, or non-profit organizations
to carry out programs to improve
biopathogen detection, develop plans for
responding to bioterrorist attacks, and train
response personnel. Requires a GAO report
to Congress at the conclusion of the
demonstration programs describing the
capabilities of the grantees. Authorizes $6
million for FY2001, and such sums as may
be necessary for FY2002–FY2006.

---

CRS-14
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Grants to Hospitals
No applicable provisions.
Amends PHS Act Section 319F by establishing
No provisions.
a grant program for hospitals and other medical
centers to improve bioterrorism preparedne s s
and response capacity. To be eligible, a
hospital must form a consortium with a public
health agency and a local government, and its
grant proposal must be consistent with the
state’s bioterrorism preparedness plan. Requires
the Secretary to develop and publish technical
guidelines relating to equipment, training,
treatment, capacity, and personnel. Authorizes
$370 million for FY2002, and such sums as may
be necessary for FY2003–FY2006. [Section
301, 311]
Grants to Address National
No applicable provisions, although PHS Act
No provisions.
Adds a new Section 319H to the PHS Act
Shortages of Specific Types of
Titles VII (Health Professionals Education)
establishing a grant program to provide
Health Professionals
and VIII (Nursing Workforce Development)
financial assistance for the education and
authorize federal support for training of
training of individuals in any category of the
health professionals for specific purposes.
health professions where there is a shortage
that the Secretary determines should be
alleviated to improve emergency readiness.
Authorizes $40 million for FY2002, and
such sums as may be necessary for
FY2003–FY2006. [Section 106, 151]
Health Professional Volunteers
No applicable provisions.
No provisions.
Adds a new Section 319I to the PHS Act
requiring the Secretary to establish a
national system to help verify the licenses,
credentials, and hospital privileges of healt h
professionals who volunteer to respond
d u r i n g p u b l i c h e a l t h e m e r g e n c i e s .
Authorizes $2 million for FY2002, and such
s u m s a s m a y b e n e c e s s a r y f o r
FY2003–FY2006. [Section 107]
S t a t e P u b l i c E m e r g e n c y
The Stafford Act (42 U.S.C. 5121 et seq.)
Amends Section 613(b) of the Stafford Act by
Same provisions as S. 1765. [Section 135]
Announcements
authorizes federal assistance when the
requiring states to include a plan for providing
President determines that a natural or man-
a coordinated public communications response
made disaster has overwhelmed state and
in their submission for federal funds to help pay
local resources. Stafford assistance is
for state emergency preparedness personnel and
administered by the Federal Emergency
administrative expenses. [Section 312]
Management Agency (FEMA).

---

CRS-15
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Countermeasures (Research, Development, and Production of New Vaccines, Drugs, and Technologies)
Antitrust Exemption
The Clayton Act (15 U.S.C. 12 et seq.) is one
Amends Section 2 of the Clayton Act to exempt
No provisions.
of the federal antitrust laws that seek to
from antitrust law meetings between the
promote fair competition and protect
Secretary and parties involved in the
consumers and businesses from anti-
d e v e l o p m e n t , m a n u f a c t u r e , d i s t r i b u t i o n ,
c o m p e t i t i v e b u s i n e s s p r a c t i c e s . I t
p u r c h a s e a n d s a l e o f n e w p r i o r i t y
enumerates specific practices that are anti-
countermeasures against bioterrorism. Permits
competitive and therefore forbidden.
the Attorney General, in consultation with the
Chairman of the Federal Trade Commission, to
grant a limited antitrust exemption to
agreements reached at such meetings. Limited
exemptions expire after 3 years, but may be
renewed. Terminates the Attorney General’s
authority to grant limited antitrust exemptions
after 6 years. [Section 401]
Smallpox Vaccine
No statutory provisions. In November 2001,
Adds new Section 2841 to the PHS Act
Authorizes $509 million for FY2002, and
HHS awarded a $428 million contact to
requiring the Secretary to ensure adequate
such sums as may be necessary for
Acambis, Inc. and Baxter International Inc.
supplies of smallpox and other vaccines in the
FY2003–FY2006, to purchase smallpox
to produce 155 million doses of smallpox
National Pharmaceutical Stockpile. Authorizes
vaccine. [Section 151]
vaccine by the end of 2002. This is in
$509 million for FY2002, and such sums as may
addition to an earlier contract with Acambis
be necessary for FY2003–FY2006, to purchase
to produce 54 million doses of the vaccine.
smallpox vaccine. Adds a new Section 2842 to
the PHS Act authorizing the Secretary to enter
into long-term contracts with companies to
purchase specific quantities of priority
countermeasures at an agreed price. [Section
402]
Research and Development
PHS Act Section 319F requires the Secretary,
A mends PHS Act Section 319F to: (i) make the
Amends PHS Act Section 319F to expand
in consultation with the interagency working
genetic sequencing of biopathogens a priority at
research on countermeasures, including the
group, to conduct research on the
NIH; and (ii) expand research on the
epidemiology and detection of biological
e p i d e m i o l o g y a n d p a t h o g e n e s i s o f
epidemiology and detection of biological
agents and toxins, and the development of
b i o p a t h o g e n s , d i a g n o s t i c t e s t s f o r
agents and toxins, and the development of new
new vaccines and therapies. Defines a
biopathogens, and vaccines and other
vaccines and therapies. [Section 403, 404]
priority countermeasure as any drug, device,
therapeutics.
biologic, or diagnostic test to treat, identify,
or prevent infection by a listed biological
agent or toxin, or prevent harm from any
other agent that may cause a pubic health
emergency. Directs the Secretary to consider
research collaboration with the VA.
[Section 125]

---

CRS-16
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
FDA Approval of Drugs and
Under the Federal Food, Drug, and Cosmetic
Aut horizes the Secretary to designate a priority
Authorizes the Secretary to designate a
Biologics
Act (FFDCA; 21 U.S.C. 301 et seq.),
countermeasure (i.e., drug or device) as a fast-
priority countermeasure (i.e., drug or
manufacturers of drugs and biologics (e.g.,
track product for accelerated approval by the
biologic) as a fast-track product for
vaccines) must provide clinical trial data to
FDA. Permits a drug seeking FDA approval on
accelerated approval by the FDA but does
demonstrate that their product is safe and
the basis of animal data to be designated a fast-
not permit a drug seeking FDA approval on
effective, in order to obtain FDA marketing
track product. Requires the FDA, within 30
the basis of animal data to be designated a
approval. The FFDCA provides for the
days, to issue as a final rule the October 5, 1999
fast-track product. Requires the FDA, within
designation of products as fast track to
proposed rule permitting the use of animal data
180 days, to issue as a final rule the October
expedite the approval process.
for approving new drugs and vaccines, when
5, 1999 proposed rule permitting the use of
ethical issues preclude conducting clinical
animal data for approving new drugs and
trials. [Section 405, 406]
vaccines, when ethical issues preclude
conducting clinical trials. [Section 122,
123]
Security at Research and
No applicable provisions.
Adds a new Section 2843 to the PHS Act
Adds a new Section 319K to the PHS Act
Production Facilities
authorizing the Secretary, in consultation with
authorizing the Secretary, in consultation
the Secretary of Defense and the Attorney
with the Secretary of Defens e and the
General, to provide technical or other assistance
Attorney General, to provide technical or
to enhance security at research and production
other assistance to enhance security at
facilities. Requires the Secretary to develop
research and production facilities. [Section
guidelines and best practices. [Section 402]
124]
D e t e c t i o n , I d e n t i f i c a t i o n ,
No applicable provisions.
No provisions.
Requires the Secretary to evaluate and
Diagnosis, and Surveillance
prioritize new and emerging technologies for
Technologies
responding to a bioterrorism attack or other
public health emergency. Requires the
Secretary to report to Congress within 180
d a y s o n t h o s e t e c h n o l o g i e s w h o s e
d e v e l o p m e n t s h o u l d b e a c c e l e r a t e d .
[Section 126]
Requires the Secretary of Energy and the
Administrator of the National Nuclear Safety
Administration, in coordination wi t h t h e
interagency working group, to expand
research on the rapid detection and
identification of biopathogens. Authorizes
such sums as may be necessary for
FY2002–FY2006. [Section 136]

---

CRS-17
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Potassium Iodide
No applicable provisions.
No provisions.
Requires the Secretary to make potassium
i o d i d e a v a i l a b l e f r o m t h e n a t i o n a l
pharmaceutical stockpile to states and local
governments that submit a plan for local
stockpile and distribution to the population
within 20 miles of a nuclear power plant.
Requires the Secretary, within 6 months, to
provide Congress with a progress report.
[Section 127]

---

CRS-18
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Antimicrobial Resistance
C o m b a t i n g A n t i m i c r o b i a l
PHS Act 319E requires the Secretary to
No provisions.
Amends PHS Act Section 319E to authorize
Resistance
establish an Antimicrobial Resistance Tas k
additional research on priority pathogens.
Force to coordinate federal programs on
Authorizes $25 million for FY2002 and for
antimicrobial resistance and to work on
FY2003, and such sums as may be necessary
surveillance plans and information systems
for FY2004–FY2006. [Section 110, 151]
for detection and control of drug-resistant
pathogens. Authorizes research and
d e v e l o p m e n t i n i t i a t i v e s f o r n e w
antimicrobial drugs and diagnostics. Directs
the Secretary to conduct a nationwide
campaign to educate the public and health
care professionals about the appropriate use
of antibiotics. Authorizes grants for public
health agencies to combat antimicrobial
resistance. Authorizes demonstration grants
for hospitals, clinics, and other entities to
promote the judicious use of antibiotics and
to control the sp read of resistant infections.
Authorizes $40 million for FY2001, and
such sums as may be necessary for
FY2002–FY2006.

---

CRS-19
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Drug and Device Supply Safety and Security
Drug and Device Importation
FFDCA Section 510(i) requires foreign drug
No provisions.
Amends Section 510(i) of the FFDCA by
and device manufacturers that import into
mandating annual registration of foreign
the United States to register with the
manufacturers engaged in the import of
Secretary their name, place of business, and
drugs and devices into the United States.
the name of their U.S. agent. Section 801
Requires registration to include the name of
governs the import and export of food, drugs,
each importer and carrier used by the
devices, and other items, and specifies the
manufacturer. Amends Section 801 so that
circumstances under which imported articles
an imported drug or device may be refused
are inspected, detained, or refused entry into
entry if the importer fails to give the
the United States.
Secretary a statement identifying each
foreign establishment that, under the law,
must also be registered. [Section 311]

---

CRS-20
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Import Components Intended
FFDCA Section 301 is the prohibited acts
No provisions.
Amends Section 801 of the F F D C A
for Export
and penalties section of the statute. Section
m a n d a t i n g a c h a i n - o f - p o s s e s s i o n
801 governs the import and export of food,
identification and a customs bond for firms
drugs, devices, and other items, and specifies
seeking to import components of drugs,
the circumstances under which imported
devices, food additives, color additives, or
articles are inspected, detained, or refused
dietary supplements for further processing
entry into the United States.
and export. Requires certificates of analysis
for components containing any chemical or
biological substance intended for e x p o r t .
Permits the Secretary to exclude from
importation any article for which there is
credible evidence or information indicating
that the article presents a serious health
threat or death to humans or animals.
Amends Section 301 making it illegal to
k n o w i n g l y s u b m i t f a l s e s t a t e m e n t s ,
certificates, records, or reports required under
Section 801, as amended. [Section 312]

---

CRS-21
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Food Supply Safety and Security
Strategic Plan for Food Safety
Executive Order 13100 created the
Requires the Council, along with the Secretaries
No provisions.
and Security
President’s Council on Food Safety, headed
of Commerce and Transportation, and in
by the Secretaries of Agriculture and Health
consultation with states, the food industry, and
and Human Services, the Administrator of
consumer and producer groups, to develop a
the Environmental Protection Agency, and
crisis communications and education strategy
the Assistant to the President for Science and
for bioterrorist threats to the food supply that
Technology. On January 18, 2001, the
includes threat assessments, response and
Council published a strategic plan for food
notification procedures, and public risk
safety which contained recommendations on
communication plans. Authorizes $500,000 for
making statutory changes to unify federal
F Y2002, and such sums as may be necessary in
food safety regulations.
each subsequent fiscal year, to implement the
strategy. [Section 511]
U.S. Department of Agriculture
USDA’s Food Safety and Inspection Service
Authorizes $15 million for enhanced FSIS
No provisions.
(USDA) Activities
(FSIS) inspects meat, poultry, and processed
inspections domestically and internationally
egg products sold for human consumption
and collaboration with other federal agencies;
for safety, wholesomeness, and proper
$30 million for APHIS for increased inspections,
labeling. The Animal and Plant Inspection
cooperative agreements with state and private
Service (APHIS) inspects cargo and
veterinarians, and an automated, integrated,
passengers at U.S. ports for animal and plant
interagency emergency warning, response, and
pests, quarantines some of these products,
record-keeping system; and $180 million for
and responds to animal disease outbreaks.
upgrading biosecurity at ARS labs in New York
The Agricultural Research Service (ARS)
and Iowa. Authorizes the Secretary of
conducts research on animal diseases and
Agriculture to use $20 million in FY2002 to
food safety to support other USDA
award up to $45,000 each to land grant
regulatory responsibilities.
universities to establish security at facilities,
inventory hazardous toxins, develop a screening
prot ocol for access to facilities, and develop
i n d u s t r y - o n - f a r m e d u c a t i o n p r o g r a m .
Authorizes a total of $245 million for FY2002
for USDA biosecurity efforts and such sums as
necessary for each fiscal year thereafter.
[Section 512, 513, 515, 527]

---

CRS-22
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
HHS and FDA Biosecurity
FFDCA Chapter IV prohibits the entry into
Requires the Secretary of HHS to secure existing
Authorizes a total of $100 million for the
interstate commerce of adulterated or
facilities where potential animal or plant
Secretary of HHS to increase inspections for
misbranded foods . FDA monitors through
pathogens are housed and researched.
the detection of intentional adulteration of
inspections whether food manufacturers
Authorizes $59 million to expand FDA’s
imported food; to give high priority to
adhere to their legal responsibility to
inspections and collaboration with other federal,
improving FDA’s information management
produce food that is not defective, unsafe,
state, and tribal agencies. Authorizes $500,000
systems; to develop tests and sampling
filthy, or produced under unsanitary
for the Secretary to develop best practices for
methods to rapidly detect intentionally
conditions.
biosecurity for use by food manufacturers,
adulterated food; and to complete an
processors, and distributors. Authorizes a total
assessment of threats to food posed by
of $59.5 million for FY2002 for HHS agencies
intentional adulteration and report its
and such sums as may be necessary for each
findings on these protective activities to
fiscal year thereafter. [Section 514,516,518]
Congress.[Section 301]
Food Detention
FFDCA Section 304 allows for the seizure of
Amends FFDCA Section 304 to authorize the
Similar to provisions in S. 1765, except that
food in interstate commerce under restricted
detention of food for 20 days, and if needed for
it limits detention approval authority to the
circumstances.
30 days, if an officer or qualified employee of
Secretary or the Secretary’s designee. It also
FDA has credible evidence (and the Secretary
does not set a time limit on the appeal, but
approves) showing the food violates the FFDCA
does require that FDA make a final decision
and presents a threat of serious adverse health
within 72 hours on the appeal. Authorizes
consequences or death to humans or animals.
the Secretary to request the Treasury
The detained food must be secured, and the
Secretary to temporarily hold imported food
responsible person can file an appeal within 15
at a port for 24 hours, if FDA has credible
days with exp edited procedures for perishable
evidence indicating that the food presents a
foods. Adds a new definition to FFDCA Section
threat, to allow FDA to determine whether to
310 prohibiting removal of product or mark or
detain it. Requires that the Secretary notify
label from the detained product. [Section 531]
the state in which the involved port is
located. [Section 302]
Debarment for Food Imports
FFDCA Section 306 gives the Secretary of
Amends FFDCA Section 306 to debar from
Similar provisions. [Section 303]
HHS authority to debar, temporarily deny
importing foods any person who is convicted of
approval, or suspend the rights of
a felony related to the importation of food or
individuals who have been convicted of a
who repeatedly imports, or knows, or should
felony to submit an application for approval
have known, that the imported food that was
of a drug.
adulterated or misbranded. Amends FFDCA
Section 402 to include in the definition of
“adulterated food” any food imported by
debarred persons. [Section 532]

---

CRS-23
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Maintenance and Inspection of
FFDCA Section 704 authorizes FDA to
Add a new Section 414 to the FFDCA allowing
Similar provisions to S. 1765, but includes
Records
conduct factory inspections. Currently, FDA
the Secretary , if a food is believed to be
language that requires the Secretary to put
inspectors have access to company records
adulterated or misbranded and presents a threat
i n t o e f f e c t p r o c e d u r e s t o p r e v e n t
but can only request access to copy, and
of serious adverse health consequences or death
unauthorized disclosure of any trade secrets
verify records for restricted medical devices,
to humans or animals, to have access to and to
or confident ial information. Also provides
prescription drugs, not for foods. Inspectors
copy all records related to the food. Excludes
authority to the Secretary to take into
may not require that records be kept nor do
restaurants and farms, and has reduced
account the size of the bus iness when
officials have authority to copy records
requirements for small businesses (less than 50
imposing any record keeping requirements.
found during inspections.
employees.) Requires records to be kept for 2
Does not impose a time limit for
years so food can be investigated. Excludes
promulgation of rules. [Section 304]
records on USDA-regulated foods (meat,
poultry, and egg products), and on trade secrets
and/or confidential information on recipes, and
financial, pricing, personnel, research, and sales
data. Amends FFDCA Section 704 to add a
clause to allow the inspection of all records and
other information described in the new Sect ion
414. Requires final rules to be issued on record
keeping within 18 months. [Section 533]
Registration of Food Facilities
Currently, only States have records of food
Creates a new Section 415 in the FFDCA
Similar provisions to S. 1765, but applies
processing, packing and holding facilities.
requiring all facilities, domestic and foreign,
requirements to facilities that manufacture,
The federal government must ask the states
that manufacture, process, and handle food to
process, pack or hold food (excludes farms.)
for this information.
register with the Secretary all the identities
Adds that the Secretary may provide for and
(brand names) under which business is
encourage the use of electronic submissions
conducted, addresses of the facilities, and
to register as long as there are authorization
general food categories. Foreign registrations
protocols used to identify the registrant and
must name a U.S. agent. Requires the Secretary
validate the data. Adds that the Secretary
to give each facility a number and keep the list
must within 60 days identify facilities
of registered facilities up to date. Exempts
required to register, and, as S. 1765, enforce
certain retail stores and farms from registration
t he registration within 180 days of the Act’s
requirements. Registration does not imply a
e n a c t m e n t . E x e m p t s o n l y r e t a i l
license. Requirements for registration would
e s t a b l i s h m e n t s f r o m r e g i s t r a t i o n
take effect 180 days after enactment. Amends
requirements. Specifies that registration
Section 403 to prohibit interstate commerce of
requirements would not apply to food
food from unregistered facilities. [Section 534]
products regulated by USDA. [Section 305]

---

CRS-24
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Prior Notice of Imported Food
Under FFDCA Section 801, a food that (i) is
Amends FFDCA Section 801 to require a
Similar provisions to S. 1765, except the
Shipments
found to be manufactured, processed, or
producer, manufacturer, or shipper of imported
a d v a n c e p e r i o d f o r s u b m i s s i o n o f
packed under unsanitary conditions, (ii) is
food, at least 4 hours before it is imported, to
documentation is to be not less than 24
forbidden or restricted in the producing
document its identity, country of origin, and
hours nor more than 72 hours before
country or from where it was exported, or (iii)
quantity imported to FDA and the U.S. Customs
importation of the food. The required
is adulterated or misbranded at the border,
or the import can be refused entry. Exempts all
information includes a description of the
can have its admission deferred while the
USDA-regulated foods (meat, poultry, and egg
food, the identity of the manufacturer and
food is reconditioned, relabeled or
products.) Prohibits knowingly making a false
shipper, if possible the grower, the country of
destroyed.
statement in the import documentation.
origin of the food, the country from which
[Section 535]
the article is shipped, and the anticipated
U.S. port of entry. Without a notice, the food
will be refused admission or held until the
required information is provided and a
determination that the food is not a serious
health threat to humans or animals. The
Secretary can ask for more information. This
provision excludes USDA regulated
products. [Section 306]
M a r k A r t i c l e s R e f u s e d
The FFDCA Section 403 defines misbranded
Amends both Sections 403 and 801(a)
Similar provisions to S. 1765. [Section 307]
Admission
foods as food whose labeling or advertising
definitions of misbranded food to include food
is false or misleading. Section 801(a) gives
that has been refused admission to the United
the Secretary the general authority to refuse
States and not destroyed and which presents a
imports deemed adulterated or misbranded.
threat of serious adverse health consequences or
death, unless the packaging is clearly and
conspicuously labeled: United States: Refused
Entry at the expense of the food’s owner until
the food is brought int o compliance. [Section
536]
Authority to Commission Other
The FFDCA Section 702 states that the
Amends FFDCA Section 702 to provide the
No provisions.
Federal Officials to Conduct
Secretary is authorized to conduct food
authority to commission qualified federal
Inspections
i n s p e c t i o n s ( e x a m i n a t i o n s a n d
officials from other departments or agencies to
i n v e s t i g a t i o n s ) t h r o u g h o f f i c e r s a n d
conduct inspections. This can only happen if
employees of HHS, or any health, food, or
there are no current laws restricting the use of a
drug officer of a state that has been duly
department or agency officers, employees, or
commissioned by the Secretary as an officer
funds. [Section 537]
of the Department.

---

CRS-25
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
P r o h i b i t i o n a g a i n s t P o r t
T h e F F D C A S e c t i o n 4 0 2 d e f i n e s
Amends FFDCA Section 402 to require that an
Similar provisions to S. 1765 except t h a t
Shopping
“adulterated” food as any food that bears or
importer offering food that has been refused
importer, at his own expense, must prove that
contains any poisonous or deleterious
admission prove at his own expense that the
the article is not adulterat ed, as determined
substance which may render it injurious to
food is in compliance with the applicable
by the Secretary. [Section 308]
health.
requirements of the Act. [Section 538]
Grants to States for Inspections
The FFDCA Section 7 0 2 s t a t e s t h a t t h e
Creates a new Section 910 in the F F D C A
Creates a new Section 909 in the FFD C A
Secretary is authorized to conduct food
authorizing $10 million for FY2002, and such
authorizing grants to states and territories to
i n s p e c t i o n s ( e x a m i n a t i o n s a n d
sums as may be necessary for subsequent fiscal
c o n d u c t f o o d s a f e t y e x a m i n a t i o n s ,
i n v e s t i g a t i o n s ) t h r o u g h o f f i c e r s a n d
years, to provide grants to states to increase food
inspections, and investigations under
employees of HHS, or any health, food, or
s a f e t y e x a m i n a t i o n s , i n s p e c t i o n s a n d
Section 702, like S. 1765, but does not
drug officer of a state that has been duly
investigations under FFDCA Section 702.
specify an amount. Also, allows grants to
commissioned by the Secretary as an officer
[Section 539]
states to assist in costs when responding to
of the Department.
adulterated food that might injure public
health. [Section 310]
Notices to States Regarding
No provisions.
No provisions.
Requires that the Secretary notify the state
Imported Food
that holds the food when there is credible
evidence that it presents a threat of serious
adverse health consequences or death to
humans or animals. [Section 309]
Rule of Construction
USDA regulates meat under the Federal Meat
Prohibits FDA from regulating any food under
No provisions.
Inspection Act (21 U.S.C. 601 et seq.),
USDA’s jurisdiction. [Section 540]
poultry under the Poultry Products
Inspection Act (21 U.S.C. 451 et seq.), and
processed egg products under the Egg
Products Inspection Act (21 U.S.C. 1031 et
seq.)
Food Safety Grants
FoodNet, established in 1995 by USDA and
Amends PHS Act Title III to authorize $19.5
No provisions.
FDA, tracks the incidence of illnesses caused
million for FY2002 in grants to states to expand
by nine pat hogens in nine geographic areas
the number participating in FoodNet and
across the United States. PulseNet compares
PulseNet and other surveillance networks and to
genetic patterns of bacteria isolated from
maintain technical and laboratory capacity.
patients with foodborne illness and/or
[Section 541]
contaminated food.
Surveillance of Animal and
CDC has more than 20 surveillance programs
Amends PHS Act Title III to authorize FDA,
No provisions.
Human Health
that monitor outbreaks of food borne illness
CDC, and USDA to develop and implement a
caused by specific pathogens.
plan for coordinating surveillance for zoonotic
and human diseases. [Section 541]

---

CRS-26
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
A g r i c u l t u r a l B i o t e r r o r i s m
Current research programs are in place in the
Expands, with an authorization of $190 million
No provisions.
Research and Development
Agricultural Research Service (ARS) and the
for FY2002 and such sums as may be necessary
Cooperative Research Service Education and
for subsequent fiscal years, the programs of
Extension Service (CSREES).
USDA’s agencies ARS and CSREES to protect
the food supply and expand links with the
intelligence community and international
organizations. [Section 542]

---

CRS-27
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Drinking Water Security and Safety
Vulnerability Assessments and
PHS Act Title XIV, the Safe Drinking Water
No provisions.
Adds a new Section 1433 to the SDWA to
Emergency Response Plans
Act (SDWA), authorizes federal regulation of
require each community water system
public water systems (including community
serving more than 3,300 individuals to
water systems), particularly through a
c o n d u c t a v u l n e r a b i l i t y a s s e s s m e n t .
program that regulates contaminants in
Requires EPA, not later than March 1, 2002,
public water supplies. The Act defines a
to provide information to community water
community water system as a public water
systems concerning probable threats.
system that serves at least 15 service
Establishes deadlines for systems to certify
connections served by year-round residents
t o E P A t h a t t h e y h a v e c o n d u c t e d
or that regularly serves at least 25 year-round
vulnerability assessments. Requires each
residents. The SDWA is administered and
community water system serving more than
enforced by the Environmental Protection
3,300 individuals to prepare or revise an
Agency (EPA).
emergency response plan incorporating the
results of the vulnerability assessment.
Systems must certify to EPA, no later than 6
months after completing an assessment, that
they have completed response plans. Directs
EPA to provide guidance to community
water systems serving fewer than 3,300
individuals on conducting vulnerability
assessments, preparing emergency respons e
plans, and addressing threats from terrorist
attacks or other actions intended to disrupt
the provision of safe drinking water.
Authorizes $120 million for FY2002, and
such sums as may be necessary for FY2003
and FY2004, to provide financial assistance
to community water systems to conduct
assessments and prepare response plans, and
for expenses and contracts to address basic
security enhancements and significant
threats. [Section 401(1)]

---

CRS-28
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Review of Methods to Prevent,
No statutory provisions.
No provisions.
Adds new SDWA Section 1434 directing the
Detect, and Respond to the
EPA Administrator, in consultation with
Intentional Introduction of
CDC, and after consultation with other
Contaminants into Community
federal departments and state and local
Water Supplies
governments, to review current and future
methods to prevent, detect and respond to
the intentional introduction of chemical,
biological or radiological contaminants into
community water sy stems and their source
waters. Provides that funding is authorized
under Section 1435. [Section 401(1)]
Supply Disruption: Prevention,
No statutory provisions.
No provisions.
Adds new SDWA Section 1435 directing the
Detection and Response
EPA Administrator, in coordination with
appropriate federal departments and
agencies, to review methods and means by
which terrorists or others could disrupt the
supply of safe drinking water or take actions
that render water unsafe, including methods
and means by which water systems could be
destroyed, impaired, or made subject to
cross-contamination. EPA must also review
methods and means by which systems could
be reasonably protected from attacks, and by
which alternative drinking water supplies
could be provided if a water system was
destroyed, impaired or contaminated.
Authorizes $15 million for FY2002, and
such sums as may be necessary for FY2003
and FY2004 to carry out Sections 1434 and
1435. [Section 401(1)]
Enforceable Requirements
SDWA Section 1414(i)(1) identifies t h e
No provisions.
Amends SDWA Section 1414(i)(1) to include
sections of SDWA for which the Act’s
new Section 1433, requiring community
enforcement authorities apply.
water systems to conduct vulnerability
assessments and to prepare emergency
response plans, as an applicable and
enforceable requirement under the Act.
[Section 401(2)]

---

CRS-29
Topic
Current Law
S. 1765 Frist/Kennedy
H.R. 3448 Tauzin/Dingell
Emergency Powers
SDWA Section 1431 grants the E P A
No provisions.
Amends SDWA Section 1431 to specify that
Administrator emergency powers to take
EPA’s emergency powers include the
such actions as deemed necessary to protect
authority to act when there is a threatened or
persons served by a public water system
potential terrorist attack or other intentional
upon receipt of information that a
act to disrupt the provision of safe drinking
contaminant which is present in or is likely
water or to impact th e s a f e t y o f a
to enter a public water system or
community’s drinking water supply.
groundwater source may present an
[Section 401(3)]
imminent and substantial endangerment to
health of those persons.
Penalties for Tampering with
SDWA Section 1432 authorizes criminal and
No provisions.
Amends SDWA Section 1432 to increase
Public Water Systems
civil penalties for persons who tamper,
criminal and civil penalties for tampering,
attempt to tamper, or threaten to tamper with
attempting to tamper, or making threats to
public water supplies.
tamper with public water supplies.
[Section 401(4)]
Technical Assistance
SDWA Section 1442(b) authorizes EPA to
No provisions.
Amends SDWA Section 1442(d) to authorize
provide technical assistance and to make
appropriations to carry out Section 1442(b)
grants to states and public water systems to
of not more than $35 million for FY2002,
assist in responding to and alleviating
and such sums as may be necessary for each
emergency situations.
fiscal year thereafter. [Section 401(5)]

---

CRS-30
Appendix A. HHS Bioterrorism Funding
FY1999–FY2001 Bioterrorism Initiative
HHS launched its bioterrorism initiative in FY1999. The initiative has six strategic
goals: prevention of bioterrorism; infectious disease surveillance; medical and public health
readiness for mass casualty events; the National Pharmaceutical Stockpile (NPS); research
and development of new drugs and vaccines; and information technology infrastructure.
Funding for these activities in the first 3 years (i.e., FY1999–FY2001) totaled about $730
million. CDC used the lion’s share of those funds to begin the process of improving the
bioterrorism preparedness and response capacity of state and local health departments.
The agency awarded grants to state and major metropolitan health departments to support
preparedness planning and readiness assessment; increase laboratory capacity for
biological and chemical agents; and create the Health Alert Network, a nationwide, secure
electronic communications network for state and local health departments. CDC has also
used some of the funds to upgrade its own facilities and laboratory capacity and to
establish and manage the NPS. In addition, HHS’s Office of Emergency Preparedness
(OEP) has expanded the National Disaster Medical System (see Table 1) and awarded
grants to strengthen emergency medical response systems in metropolitan areas.
FY2002 Funding
For FY2002, Congress appropriated $3 billion to HHS to improve bioterrorism
preparedness at the federal, state, and local levels. Bioterrorism funding was included in
both the FY2002 Labor-HHS-Education appropriations bill and the anti-terrorism
emergency spending package.
Labor-HHS-Education Appropriations. The FY2002 Labor-HHS-
Education appropriations act (P.L. 107-116, H.R. 3061) included $243 million for the
bioterrorism initiative: $182 million for CDC and $61 million for OEP.
Emergency Supplemental Appropriations. Congress passed a $40 billion
emergency supplemental appropriations bill (P.L. 107-38, H.R. 2888) within days of the
September 11 attacks to provide aid to the victims, repair damaged public facilities and
transportation systems, expand law enforcement activities, and strengthen counter-
terrorism capabilities. The first $10 billion was available immediately for allocation by the
President. An additional $10 billion was available 15 days after the President notified
Congress about how he would distribute the funds. In a series of notifications beginning
on September 21, 2001, the Administration allocated all but $327 million of the first $20
billion before the 15-day prior notification period expired on November 25. Those
allocations included $121 million for HHS to provide emergency assistance for health care
and social services in the New York and Washington, DC, metropolitan areas.2
2 The funds were used to provide emergency grants to health care providers, community
health centers, and mental health and substance abuse centers, and to provide services for
the disabled, home-delivered meals, and transportation for senior citizens in affected areas.

---

CRS-31
The second $20 billion was made subject to the appropriations process and was
included as an amendment to the FY2002 Defense Department appropriations bill (P.L.
107-117, H.R. 3338). As enacted, H.R. 3338 provides HHS a total of $2.8 billion for
bioterrorism-related activities. The appropriations act allocates that funding under several
broad categories, including $593 million for the NPS, $512 million to purchase smallpox
vaccine, $865 million for state and local health departments, $135 million to upgrade
hospital capacity, $100 million to upgrade CDC’s facilities and capacity, $155 for NIH
research and lab construction, and $151 for FDA lab security, vaccine approval, and food
safety. The act also provides $140 million to reimburse Medicare, Medicaid, and other
health care providers for expenses or lost revenues attributable to the September 11
attacks.
While lawmakers work towards final passage of new bioterrorism authorizing
legislation, CDC and the Health Resources and Services Administration (HRSA) have
awarded a total of $1 billion in FY2002 funds to upgrade state and local health
departments and improve hospital preparedness and response capacity. See Appendix
B for more information on these grant programs.
FY2003 Budget Request
The President’s FY2003 budget would provide a total of $4.3 billion for HHS’s
bioterrorism preparedness programs and activities. The budget request includes funds for
strengthening the federal medical and public health response capacity, upgrading CDC’s
facilities, improving state and local public health preparedness, developing vaccines and
maintaining the National Pharmaceutical Stockpile, preparing the nation’s hospitals,
expanding FDA’s regulatory oversight of drugs and biologics, and securing facilities to
conduct critical scientific work. Table 2 summarizes HHS’s bioterrorism funding in
FY2001, FY2002, and the FY2003 budget request.
Note that the table does not include the funding provided for recovery and relief
efforts in response to the September 11 attacks (e.g., $121 million in emergency assistance
to New York and Washington, DC, and $140 million to reimburse health care providers).

---

CRS-32
Table 2. HHS Bioterrorism Funding ($ millions)
FY200
FY2002
FY2003
Agency and Program
1
Enacte
Request
Actual
d
Centers for Disease Control and Prevention (CDC)
State and local public health preparedness
67
940
940
CDC capacity
22
116
144
National Pharmaceutical Stockpile
51
645
300
Smallpox vaccine procurement
0
512
100
Physical security and facilities
3
46
120
Othera
39
39
33
Subtotal, CDC
$181
$2,298
$1,637
Health Resources and Services Admin. (HRSA)
Hospital preparedness and infrastructure
0
135
518
Otherb
0
0
100
Subtotal, HRSA
$0
$135
$618
Food and Drug Administration (FDA)
Food safety
1
98
98
Vaccine and drug approval
6
47
54
Physical security
2
13
7
Subtotal, FDA
$8
$158
$159
National Institutes of Health (NIH)
Research
53
183
977
Physical security and facilities
0
92
521
Anthrax vaccine procurement
0
0
250
Subtotal, NIH
$53
$274
$1,748
Office of the Secretary (OS)
Office of Emergency Preparednessc
33
76
117
Office of Public Health Preparedness
30
41
33
Subtotal, OS
$63
$117
$150
Substance Abuse & Mental Health Services
0
0
10
Admin.

---

CRS-33
TOTAL, HHS Bioterrorism
$305
$2,982
$4,322
Source: Dept. Health and Human Services FY2003 Budget Request
Note: Columns may not add due to rounding.
a Includes funding for anthrax vaccine evaluation and research, and national planning.
b Includes funding for poison control centers, medical curricula, and addressing children’s
needs.
c Includes funding for the National Disaster Medical System (NDMS), the Metropolitan
Medical Response Systems (MMRS) program, and HHS cybersecurity.

---

CRS-34
Appendix B. CDC and HRSA Bioterrorism
Preparedness Grant Programs
For FY2002, Congress provided $940 million to CDC to upgrade state and local
public health departments and $135 million to HRSA to increase hospital preparedness
(see Table 2).
State and Local Public Health Department Preparedness
CDC established a cooperative agreement program (pursuant to authority in PHS
Act Sections 319B, 319C, and 319F) to improve the preparedness of state and local
public health departments to respond to bioterrorism, infectious disease outbreaks, and
other public health threats and emergencies. On February 19, 2002, using a population-
based allocation formula, CDC awarded $918 million in grants to the health departments
of all 50 states, Washington DC, the five territories, and the nation’s three largest cities
(New York, Chicago, and Los Angeles County). While 20% of the award is available for
immediate use, the remaining 80% is contingent on the approval of a state work plan to be
submitted to CDC no later than April 15, 2002. According to the agency’s guidance
documents, work plans must describe the activities to be undertaken to develop and
expand critical capacities in the following areas: preparedness planning and readiness
assessment; surveillance and epidemiology; laboratory capacity; communications and
information technology; and education and training. For more information on CDC’s grant
program, go to [http://www.bt.cdc.gov/Planning/CoopAgreementAward/index.asp].
Hospital Preparedness
HRSA’s cooperative agreement program provides grants to improve the capacity of
hospitals and other health care facilities to care for the victims of bioterrorism, natural
infectious disease outbreaks, and other public health emergencies. The agency has
awarded $125 million to the same entities that received CDC funding, using a similar
population-based allocation formula. As with the CDC grants, the funds are being
released in two phases. Phase one funding (20% of the total award) is subject to an
application filed no later than Feb. 25, 2002. Phase two funding (80% of the total award)
is contingent on an approved work plan due no later than April 15, 2002. Grantees are
required to provide at least 80% of the phase two funds to hospitals. For more information
o n H R S A ’ s h o s p i t a l p r e p a r e d n e s s g r a n t p r o g r a m , g o t o
[http://www.hrsa.gov/bioterrorism.htm].
Coordination and Review of State Work Plans
DHHS has encouraged states to develop their public health and hospital
preparedness plans in tandem. In an effort to ensure that the CDC and HRSA funds are
used in a coordinated manner, grantees are required to submit both work plans to their
governor (or mayor in the case of the municipalities) for approval. The governor (or
mayor) is then required to transmit a letter of endorsement to the department. To date,
HRSA has received 47 state work plans and granted extensions to three states. Montana
and Utah have each received a one-month extension (until May 15), and Texas has been

---

CRS-35
granted an extension until July 1. CDC has received 48 state work plans and granted one-
month extensions to Montana and Utah. All four municipalities (i.e., Washington DC, New
York City, Chicago, and Los Angeles County) have submitted their work plans to CDC
and HRSA. The department’s goal is to release all the grant funds to each state and
municipality within 30 days of receipt of both work plans and the letter of endorsement
from the governor (or mayor). For a table showing the amount of CDC and HRSA
funding each state, territory, and municipality has received, go to
[http://www.hhs.gov/news/press/2002
pres/states.html].

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CRS-36
Appendix C. Bioterrorism-Related Hearings
(107th Congress)
Senate Appropriations Subcommittee on Labor, HHS, and Education
October 3, 2001
Bioterrorism: Public health preparedness and response
October 23, 2001
Public health response to anthrax attack
November 2, 2001
Smallpox: Public health preparedness and response
November 29, 2001
Funding for bioterrorism preparedness
Senate Appropriations Subcommittee on VA-HUD and Independent
Agencies
November 28, 2001
Anthrax decontamination
Senate Armed Services Subcommittee on Emerging Threats and Capabilities
October 25, 2001
Bioterrorism and the Dark Winter exercise
Senate Commerce, Science and Transportation Committee
February 5, 2002
Bioterrorism: Countermeasures R&D (Subcommittee on
Science, Technology, and Space)
Senate Environment and Public Works Committee
December 4, 2001
Anthrax decontamination
Senate Foreign Relations Committee
September 5, 2001
Bioterrorism threat and the spread of infectious diseases
Senate Governmental Affairs Committee
July 23, 2001
Bioterrorism: FEMA’s role and public health preparedness
(Subcommittee on National Security, Proliferation and
Federal Services)
October 17, 2001
Bioterrorism: Federal agency preparedness
October 30-31, 2001
Anthrax in the mail: Protecting postal workers and the public
April 18, 2002
Public health preparedness

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CRS-37
Senate Health, Education, Labor, and Pensions Committee
September 26, 2001
Psychological trauma of terrorism
October 9, 2001
Bioterrorism: Public health preparedness and response
November 2, 2001
Kids and terrorism (Subcommittee on Children and
Families)
Senate Judiciary Committee
November 6, 2001
Law enforcement and the domestic bioterrorism threat
(Subcommittee on Technology, Terrorism and Government
Information)
House Appropriations Subcommittee on Labor, HHS, and Education
May 1, 2002
HHS bioterrorism preparedness
House Energy and Commerce Committee
October 10, 2001
Bioterrorism preparedness and response (Subcommittee on
Oversight and Investigations)
November 1, 2001
Public health early-warning surveillance systems
(Subcommittee on Oversight and Investigations)
November 7, 2001
Physical security and NIH and CDC facilities (Subcommittee
on Oversight and Investigations)
November 15, 2001
Bioterrorism: Public health preparedness and response
House Government Reform Committee
May 1, 2001
Management of medical stockpiles (Subcommittee on
National Security, Veterans Affairs and International
Relations)
July 23, 2001
Federal response to a bioterrorism attack: Dark Winter
(Subcommittee on National Security, Veterans Affairs and
International Relations)
October 5, 2001
Bioterrorism: Federal, state, and local preparedness
(Subcommittee on Government Efficiency, Financial
Management and Intergovernmental Relations)
October 12, 2001
Assessing the threat of bioterrorism (Subcommittee on
National Security, Veterans Affairs and International
Relations)
October 23, 2001
Vaccine research and development (Subcommittee on
National Security, Veterans Affairs and International
Relations)

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CRS-38
October 30, 2001
Anthrax and postal worker safety
November 7, 2001
DOD medical readiness for chemical and biological warfare
(Subcommittee on National Security, Veterans Affairs and
International Relations)
November 14, 2001
Medical care for bioterrorism victims
November 29, 2001
Risk communication: National security and public health
(Subcommittee on National Security, Veterans Affairs and
International Relations)
December 14, 2001
Bioterrorism response: Information sharing between local,
state, and federal governments (Subcommittee on
Technology and Procurement Policy)
February 28, 2002
Anthrax antitoxin research
March 1, 2002
Federal, state, and local response to biological and chemical
attack (Subcommittee on Government Efficiency, Financial
Management and Intergovernmental Relations)
March 21, 2002
Combating terrorism (Subcommittee on National Security,
Veterans Affairs and International Relations)
House International Relations Committee
December 5, 2001
Bioterrorism and potential sources of anthrax
House Science Committee
November 8, 2001
Anthrax decontamination
December 5, 2001
Bioterrorism: Federal preparedness and response
House Veterans’ Affairs Committee
April 10, 2002
Bioterrorism legislation (H.R. 3253, H.R. 3254)

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CRS-39
Appendix D. Bioterrorism-Related Web Sites
Department of Health and Human Services
Information on public health preparedness
[http://www.hhs.gov/hottopics/healing]
DHHS Office of Emergency Preparedness
[http://www.oep.dhhs.gov]
DHHS Office of Public Health Preparedness
[http://www.hhs.gov/ophp]
Metropolitan Medical Response Systems
[http://www.mmrs.hhs.gov]
National Pharmaceutical Stockpile Program
[http://www.cdc.gov/nceh/nps]
Centers for Disease Control and Prevention
[http://www.bt.cdc.gov]
Health Resources and Services Admin.
[http://www.hrsa.gov/bioterrorism.htm]
Food and Drug Administration
[http://www.fda.gov/oc/opacom/hottopics/bioterrorism.html]
National Institutes of Health
[http://www.niaid.nih.gov/publications/bioterrorism.htm]
National Library of Medicine
[http://www.nlm.nih.gov/medlineplus/biologicalandchemicalweapons.html]
Department of Defense
U.S. Army Medical Research Institute of Infectious Diseases
[http://www.usamriid.army.mil]
DOD Anthrax Vaccine Immunization Program
[http://www.anthrax.osd.mil]
Nuclear, Biological, Chemical Medical Reference Site
[http://www.nbc-med.org/others]
State and Local Health Departments
Many health departments have included information on bioterrorism and public health preparedness on their Web sites.
For links to state and local health departments, go to [http://www.apha.org/public_health/state.htm].
Professional Associations
American College of Emergency Physicians
[http://www.acep.org/1,4634,0.html]
American College of Physicians
[http://www.acponline.org/bioterro]
American Hospital Association
[http://www.aha.org/Emergency/EmIndex.asp]
American Medical Association
[http://www.ama-assn.org/ama/pub/category/6671.html]
American Society for Microbiology
[http://www.asm.org/pcsrc/bioprep.htm]
Association for Professionals in Infection Control and Epidemiology
[http://www.apic.org/bioterror]
Association of State and Territorial Health Officials
[http://www.astho.org/infectious/emerging.html]

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CRS-40
Council of State and Territorial Epidemiologists
[http://www.cste.org]
Federation of American Scientists, Chemical & Biological Arms Control Program
[http://fas.org/bwc]
Nat. Assoc. of County & City Health Officials
[http://www.naccho.org/files/documents/responds_to_bioterrorism.html]
Academic Resources
Johns Hopkins Center for Civilian Biodefense Studies
[http://www.hopkins-biodefense.org]
The Henry L. Stimson Center
[http://www.stimson.org/cbw]
Monterey Institute of International Studies
[http://www.cns.miis.edu]
Chemical and Biological Arms Control Institute
[http://www.cbaci.org]
UCLA Center for Public Health and Disaster Relief
[http://www.ph.ucla.edu/cphdr]
University of Minnesota Center for Infectious Disease Research and Policy
[http://www1.umn.edu/cidrap]
St. Louis University Center for the Study of Bioterrorism and Emerging Infections
[http://bioterrorism.slu.edu]

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