SECTION. 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Public Health Security and Bioterrorism Response Act
of 2001’’.
(b) TABLE OF CONTENTS.—The table of contents of
the Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I—NATIONAL PREPAREDNESS FOR BIOTERRORISM AND
OTHER PUBLIC HEALTH EMERGENCIES
Subtitle A—National Preparedness and Response Planning, Coordinating, and
Reporting
Sec. 101. National preparedness and response.
Sec. 102. Assistant Secretary for Emergency Preparedness; National Disaster
Medical System.
Sec. 103. Improving ability of Centers for Disease Control and Prevention with
respect to bioterrorism and other public health emergencies; fa-
cilities.
Sec. 104. Advisory committees and communications.
Sec. 105. Education of health care personnel; training regarding pediatric
issues.
Sec. 106. Grants regarding shortages of certain health professionals.
Sec. 107. Emergency system for verification of credentials of health professions
volunteers.
Sec. 108. Enhancing preparedness activities for bioterrorism and other public
health emergencies.
Sec. 109. Improving State and local core public health capacities.
Sec. 110. Antimicrobial resistance program.
Sec. 111. Study regarding communications abilities of public health agencies.
Sec. 112. Supplies and services in lieu of award funds.
Sec. 113. Additional amendments.
Sec. 114. Study regarding local emergency response methods.
Subtitle B—National Stockpile; Development of Priority Countermeasures
Sec. 121. National stockpile.
Sec. 122. Accelerated approval of priority countermeasures.
Sec. 123. Use of animal trials in approval of certain drugs and biologics;
issuance of rule.
Sec. 124. Security for countermeasure development and production.
Sec. 125. Accelerated countermeasure research and development.
Sec. 126. Evaluation of new and emerging technologies regarding bioterrorist
attack and other public health emergencies.
Sec. 127. Potassium iodide.
Subtitle C—Emergency Authorities; Additional Provisions
Sec. 131. Expanded authority of Secretary of Health and Human Services to
respond to public health emergencies.
Sec. 132. Streamlining and clarifying communicable disease quarantine provi-
sions.
Sec. 133. Emergency waiver of Medicare, Medicaid, and SCHIP requirements.
Sec. 134. Provision for expiration of public health emergencies.
Sec. 135. Designated State public emergency announcement plan.
Sec. 136. Expanded research by Secretary of Energy.
Sec. 137. Agency for Toxic Substances and Disease Registry.
Sec. 138. Expanded research on worker health and safety.
Sec. 139. Technology opportunities program support.
Subtitle D—Authorization of Appropriations
Sec. 151. Authorization of Appropriations.
TITLE II—ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL
AGENTS AND TOXINS
Sec. 201. Regulation of certain biological agents and toxins.
TITLE III-AMENDMENTS TO FEDERAL FOOD, DRUG, AND
COSMETIC ACT
Subtitle A—Protection of Food Supply
Sec. 301. Protection against intentional adulteration of food.
Sec. 302. Administrative detention.
Sec. 303. Permissive debarment regarding food importation.
Sec. 304. Maintenance and inspection of records for foods.
Sec. 305. Registration.
Sec. 306. Prior notice of imported food shipments.
Sec. 307. Authority to mark articles refused admission into United States.
Sec. 308. Prohibition against port shopping for importation.
Sec. 309. Notices to States regarding imported food.
Sec. 310. Grants to States for inspections; response to notice regarding adulter-
ated imported food.
Subtitle B—Protection of Drug Supply
Sec. 311. Annual registration of foreign manufacturers; shipping information;
drug and device listing.
Sec. 312. Requirement of additional information regarding import components
intended for use in export products.
TITLE IV-DRINKING WATER SECURITY AND SAFETY
Sec. 401. Amendment of the Safe Drinking Water Act.
TITLE I—NATIONAL PREPARED-
NESS 
FOR 
BIOTERRORISM
AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A—National Preparedness
and Response Planning, Coordi-
nating, and Reporting
SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.
The Public Health Service Act (42 U.S.C. 201 et
seq.) is amended by adding at the end the following title:
‘‘TITLE XXVIII—NATIONAL PRE-
PAREDNESS 
FOR 
BIOTER-
RORISM AND OTHER PUBLIC
HEALTH EMERGENCIES
‘‘Subtitle 
A—National 
Prepared-
ness and Response Planning,
Coordinating, and Reporting
‘‘SEC. 2801. NATIONAL PREPAREDNESS PLAN.
‘‘(a) IN GENERAL.—
‘‘(1) PREPAREDNESS AND RESPONSE REGARD-
ING PUBLIC HEALTH EMERGENCIES.—The Secretary
shall further develop and implement a coordinated
strategy, building upon the core public health capa-
bilities established pursuant to section 319A, for
carrying out health-related activities to prepare for
and respond effectively to bioterrorism and other
public health emergencies, including the preparation
of a plan under this section. The Secretary shall pe-
riodically thereafter review and as appropriate revise
the plan.
‘‘(2) CONSULTATION.—The Secretary shall
carry out paragraph (1) in consultation with the
Secretary of Defense, the Director of the Federal
Emergency Management Agency, the Secretary of
Veterans Affairs, the Attorney General, the Sec-
retary of Agriculture, the Secretary of Energy, the
Secretary of Labor, and the Administrator of the
Environmental Protection Agency, and with other
appropriate public and private entities.
‘‘(3) NATIONAL
APPROACH.—In carrying out
paragraph (1), the Secretary shall collaborate with
the States toward the goal of ensuring that the ac-
tivities of the Secretary regarding bioterrorism and
other public health emergencies are coordinated with
activities of the States, including through local gov-
ernments, such that there is a national plan for pre-
paredness for and responding effectively to such
emergencies.
‘‘(4) EVALUATION
OF
PROGRESS.—The plan
under paragraph (1) shall provide for specific bench-
marks and outcome measures for evaluating the
progress of the Secretary and the States, including
local governments, with respect to the plan under
paragraph (1), including progress toward achieving
the goals specified in subsection (b).
‘‘(b) PREPAREDNESS GOALS.—The plan under sub-
section (a) shall include provisions for achieving the fol-
lowing goals with respect to preparedness for and respond-
ing effectively to bioterrorism and other public health
emergencies:
‘‘(1) Providing effective assistance to State and
local governments in the event of such an emer-
gency.
‘‘(2) Ensuring that State and local governments
have adequate and appropriate capacity to detect
and respond effectively to such emergencies, includ-
ing capacities for the following:
‘‘(A) Effective public health surveillance
and reporting mechanisms at the State and
local levels.
‘‘(B) Adequate laboratory readiness.
‘‘(C) Properly trained and equipped emer-
gency response, public health, and medical per-
sonnel.
‘‘(D) Health and safety protection of work-
ers involved in responding to such an emer-
gency.
‘‘(E) Public health agencies that are pre-
pared to coordinate health services (including
mental health services) during and after such
emergencies.
‘‘(F) Participation in communications net-
works that can effectively disseminate relevant
information in a timely and secure manner to
appropriate public and private entities and to
the public.
‘‘(3) Developing and maintaining medical coun-
termeasures (such as drugs, vaccines and other bio-
logical products, and medical devices) against bio-
logical agents that may be used in such emergencies.
‘‘(4) Ensuring coordination and minimizing du-
plication of Federal, State, and local planning, pre-
paredness, and response activities, including among
agencies during the investigation of a suspicious dis-
ease outbreak.
‘‘(5) Ensuring adequate readiness of hospitals
and other health care facilities to respond effectively
to such emergencies.
‘‘(c) EVALUATION
OF USING VA R&D CAPABILI-
TIES.—The Secretary shall evaluate the feasibility of using
the biomedical research and development capabilities of
the Department of Veterans Affairs, in conjunction with
that Department’s affiliations with health-professions uni-
versities, as a means to assist the Secretary in achieving
the goals specified in subsection (b).
‘‘(d) REPORTS TO CONGRESS.—
‘‘(1) INITIAL REPORT TO CONGRESS.—Not later
than one year after the date of the enactment of the
Public Health Security and Bioterrorism Response
Act of 2001, the Secretary shall submit to the Com-
mittee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, a report
concerning progress with respect to the plan under
subsection (a), including progress toward achieving
the goals specified in subsection (b).
‘‘(2) BIENNIAL
REPORTS.—Not later than 2
years after the date on which the report under para-
graph (1) is submitted, and biennially thereafter, the
Secretary shall submit to each of the committees
specified in such paragraph a report concerning the
progress made with respect to the plan under sub-
section (a), including the goals under subsection (b).
‘‘(3) ADDITIONAL
AUTHORITY.—Reports sub-
mitted under paragraph (2) by the Secretary shall
make recommendations concerning—
‘‘(A) any additional legislative authority
that the Secretary determines is necessary for
fully implementing the plan under subsection
(a), including meeting the goals under sub-
section (b); and
‘‘(B) any additional legislative authority
that the Secretary determines is necessary
under section 319 to protect the public health
in the event that a condition described in sec-
tion 319(a) occurs.
‘‘(e) OTHER REPORTS.—Not later than one year
after the date of the enactment of the Public Health Secu-
rity and Bioterrorism Response Act of 2001, the Secretary
shall submit to each of the committees specified in para-
graph (1) a report concerning—
‘‘(1) the recommendations and findings of the
EPIC 
Advisory 
Committee 
under 
section
319F(c)(3);
‘‘(2) the characteristics that may render a rural
community uniquely vulnerable to a biological at-
tack, including distance, lack of emergency trans-
port, hospital or laboratory capacity, lack of integra-
tion of Federal or State public health networks,
workforce deficits, or other relevant conditions;
‘‘(3) the characteristics that may render areas
or populations designated as medically underserved
populations (as defined in section 330) uniquely vul-
nerable to a biological attack, including significant
numbers of low-income or uninsured individuals,
lack of affordable and accessible health care services,
insufficient public and primary health care re-
sources, lack of integration of Federal or State pub-
lic health networks, workforce deficits, or other rel-
evant conditions; and
‘‘(4) the recommendations of the Secretary with
respect to additional legislative authority that the
Secretary determines is necessary to effectively
strengthen rural communities, or medically under-
served populations (as defined in section 330).
‘‘(f) RULE OF CONSTRUCTION.—This section may
not be construed as expanding or limiting any of the au-
thorities of the Secretary that, on the day before the date
of the enactment of the Public Health Security and Bio-
terrorism Response Act of 2001, were in effect with re-
spect to preparing for and responding effectively to bioter-
rorism and other public health emergencies.’’.
SEC. 102. ASSISTANT SECRETARY FOR EMERGENCY PRE-
PAREDNESS; NATIONAL DISASTER MEDICAL
SYSTEM.
(a) IN GENERAL.—Title XXVIII of the Public Health
Service Act, as added by section 101 of this Act, is amend-
ed by adding at the end the following subtitle:
‘‘Subtitle B—Emergency
Preparedness and Response
‘‘SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND
RESPONSE TO BIOTERRORISM AND OTHER
PUBLIC HEALTH EMERGENCIES.
‘‘(a) ASSISTANT SECRETARY FOR EMERGENCY PRE-
PAREDNESS.—
‘‘(1) IN GENERAL.—There is established within
the Department of Health and Human Services the
position of Assistant Secretary for Emergency Pre-
paredness. The President, by and with the advice
and consent of the Senate, shall appoint an indi-
vidual to serve in such position. Such Assistant Sec-
retary shall report to the Secretary.
‘‘(2) DUTIES.—Subject to the authority of the
Secretary, the Assistant Secretary for Emergency
Preparedness shall carry out the following duties:
‘‘(A) 
Coordinate 
on 
behalf 
of 
the
Secretary—
‘‘(i) all interagency interfaces between
the Department of Health and Human
Services (referred to in this paragraph as
the ‘Department’) and other departments,
agencies and offices of the United States,
including the activities of the joint inter-
departmental working groups under sub-
sections (a) and (b) of section 319F; and
‘‘(ii) all interfaces between the De-
partment and State and local entities with
responsibility for emergency preparedness.
‘‘(B) Coordinate the operations of the Na-
tional Disaster Medical System and any other
emergency response activities within the De-
partment of Health and Human Services that
are related to bioterrorism or public health
emergencies.
‘‘(C) Coordinate the efforts of the Depart-
ment to bolster State and local emergency pre-
paredness for a bioterrorist attack or other pub-
lic health emergency, and evaluate the progress
of such entities in meeting the benchmarks and
other outcome measures contained in the na-
tional plan and in meeting the core public
health capabilities established pursuant to
319A.
‘‘(D) Coordinate the activities of the De-
partment with respect to research and develop-
ment of priority vaccines, other biological prod-
ucts, drugs, and devices useful for detecting or
responding to a bioterrorist attack or other
public health emergency.
‘‘(E) Coordinate the activities of the De-
partment with respect to public education,
awareness, and information relating to bioter-
rorism or other public health emergencies, in-
cluding the activities and recommendations of
the EPIC Advisory Committee under section
319F(c)(3).
‘‘(F) Coordinate all other functions within
the Department of Health and Human Services
relating to emergency preparedness, including
matters relating to bioterrorism and other pub-
lic health emergencies that are addressed in the
national plan under section 2801.
‘‘(G) Any other duties determined appro-
priate by the Secretary.
‘‘(b) NATIONAL DISASTER MEDICAL SYSTEM.—
‘‘(1) IN GENERAL.—The Secretary shall provide
for the operation in accordance with this section of
a system to be known as the National Disaster Med-
ical System (in this section referred to as the ‘Na-
tional System’). The Secretary shall designate the
Assistant Secretary for Emergency Preparedness as
the head of the National System, subject to the au-
thority of the Secretary.
‘‘(2) FEDERAL
AND
STATE
COLLABORATIVE
SYSTEM.—
‘‘(A) IN GENERAL.—The National System
shall be a coordinated effort by the Federal
agencies specified in subparagraph (B), working
in collaboration with the States and other ap-
propriate public or private entities, to carry out
the purposes described in paragraph (3).
‘‘(B) 
PARTICIPATING
FEDERAL
AGEN-
CIES.—The Federal agencies referred to in sub-
paragraph (A) are the Department of Health
and Human Services, the Federal Emergency
Management Agency, the Department of De-
fense, and the Department of Veterans Affairs.
‘‘(3) PURPOSE OF SYSTEM.—
‘‘(A) IN
GENERAL.—The Secretary may
activate the National System to—
‘‘(i) provide health services, health-re-
lated social services, other appropriate
human services, and appropriate auxiliary
services to respond to the needs of victims
of a public health emergency (whether or
not determined to be a public health emer-
gency under section 319); or
‘‘(ii) be present at locations, and for
periods of time, specified by the Secretary
on the basis that the Secretary has deter-
mined that a location is at risk of a public
health emergency during the time speci-
fied.
‘‘(B) ONGOING ACTIVITIES.—The National
System shall carry out such ongoing activities
as may be necessary to prepare for the provi-
sion of services described in subparagraph (A)
in the event that the Secretary activates the
National System for such purposes.
‘‘(C) TEST
FOR
MOBILIZATION
OF
SYS-
TEM.—During the one-year period beginning on
the date of the enactment of the Public Health
Security and Bioterrorism Response Act of
2001, the Secretary shall conduct an exercise to
test the capability and timeliness of the Na-
tional System to mobilize and otherwise respond
effectively to a bioterrorist attack or other pub-
lic health emergency that affects two or more
geographic locations concurrently. Thereafter,
the Secretary may periodically conduct such ex-
ercises regarding the National System as the
Secretary determines to be appropriate.
‘‘(c) CRITERIA.—
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish criteria for the operation of the National Sys-
tem.
‘‘(2) EDUCATION
AND
TRAINING
OF
PER-
SONNEL.—In carrying out paragraph (1), the Sec-
retary shall establish criteria regarding the edu-
cation and training of individuals who provide emer-
gency services through the National System. In the
case of permanent, full-time positions in the Depart-
ment of Health and Human Services that involve
significant supervisory roles within the National Sys-
tem, the criteria shall require that individuals in
such positions have completed appropriate education
or training programs as determined by the Sec-
retary.
‘‘(3) PARTICIPATION
AGREEMENTS
FOR
NON-
FEDERAL ENTITIES.—In carrying out paragraph (1),
the Secretary shall establish criteria regarding the
participation of States and private entities in the
National System, including criteria regarding agree-
ments for such participation. The criteria shall in-
clude the following:
‘‘(A) Provisions relating to the custody and
use of Federal personal property by such enti-
ties, which may in the discretion of the Sec-
retary include authorizing the custody and use
of such property on a reimbursable basis to re-
spond to emergency situations for which the
National System has not been activated by the
Secretary pursuant to subsection (b)(3)(A).
‘‘(B) Provisions relating to circumstances
in which an individual or entity has agreements
with both the National System and another en-
tity regarding the provision of emergency serv-
ices by the individual. Such provisions shall ad-
dress the issue of priorities among the agree-
ments involved.
‘‘(d) INTERMITTENT
DISASTER-RESPONSE
PER-
SONNEL.—
‘‘(1) IN GENERAL.—For the purpose of assist-
ing the National System in carrying out duties
under this section, the Secretary may appoint indi-
viduals to serve as intermittent personnel of such
System in accordance with applicable civil service
laws and regulations.
‘‘(2) LIABILITY.—For purposes of section
224(a) and the remedies described in such section,
an individual appointed under paragraph (1) shall,
while acting within the scope of such appointment,
be considered to be an employee of the Public
Health Service performing medical, surgical, dental,
or related functions. With respect to the participa-
tion of individuals appointed under paragraph (1) in
training programs authorized by the Assistant Sec-
retary for Emergency Preparedness or a comparable
official of any Federal agency specified in subsection
(b)(2)(B), acts of individuals so appointed that are
within the scope of such participation shall be con-
sidered within the scope of the appointment under
paragraph (1) (regardless of whether the individuals
receive compensation for such participation).
‘‘(e) CERTAIN EMPLOYMENT ISSUES REGARDING
INTERMITTENT APPOINTMENTS.—
‘‘(1) INTERMITTENT
DISASTER-RESPONSE
AP-
POINTEE.—For purposes of this subsection, the term
‘intermittent disaster-response appointee’ means an
individual appointed by the Secretary under sub-
section (d).
‘‘(2) COMPENSATION FOR WORK INJURIES.—An
intermittent disaster-response appointee shall, while
acting in the scope of such appointment, be consid-
ered to be an employee of the Public Health Service
performing medical, surgical, dental, or related func-
tions, and an injury sustained by such an individual
shall be deemed ‘in the performance of duty’, for
purposes of chapter 81 of title 5, United States
Code, pertaining to compensation for work injuries.
With respect to the participation of individuals ap-
pointed under subsection (d) in training programs
authorized by the Assistant Secretary for Emergency
Preparedness or a comparable official of any Federal
agency specified in subsection (b)(2)(B), injuries
sustained by such an individual, while acting within
the scope of such participation, also shall be deemed
‘in the performance of duty’ for purposes of chapter
81 of title 5, United States Code (regardless of
whether the individuals receive compensation for
such participation). In the event of an injury to such
an intermittent disaster-response appointee, the Sec-
retary of Labor shall be responsible for making de-
terminations as to whether the claimant is entitled
to compensation or other benefits in accordance with
chapter 81 of title 5, United States Code.
‘‘(3) 
EMPLOYMENT
AND
REEMPLOYMENT
RIGHTS.—
‘‘(A) IN GENERAL.—Service as an inter-
mittent disaster-response appointee when the
Secretary activates the National System or
when the individual participates in a training
program authorized by the Assistant Secretary
for Emergency Preparedness or a comparable
official of any Federal agency specified in sub-
section (b)(2)(B) shall be deemed ‘service in the
uniformed services’ for purposes of chapter 43
of title 38, United States Code, pertaining to
employment and reemployment rights of indi-
viduals who have performed service in the uni-
formed services (regardless of whether the indi-
vidual receives compensation for such participa-
tion). All rights and obligations of such persons
and procedures for assistance, enforcement, and
investigation shall be as provided for in chapter
43 of title 38, United States Code.
‘‘(B) NOTICE OF ABSENCE FROM POSITION
OF EMPLOYMENT.—Preclusion of giving notice
of service by necessity of Service as an intermit-
tent disaster-response appointee when the Sec-
retary activates the National System shall be
deemed preclusion by ‘military necessity’ for
purposes of section 4312(b) of title 38, United
States Code, pertaining to giving notice of ab-
sence from a position of employment. A deter-
mination of such necessity shall be made by the
Secretary, in consultation with the Secretary of
Defense, and shall not be subject to judicial re-
view.
‘‘(4) LIMITATION.—An intermittent disaster-re-
sponse appointee shall not be deemed an employee of
the Department of Health and Human Services for
purposes other than those specifically set forth in
this section.
‘‘(f) DEFINITION.—For purposes of this section, the
term ‘auxiliary services’ includes mortuary services, veteri-
nary services, and other services that are determined by
the Secretary to be appropriate with respect to the needs
referred to in subsection (b)(3)(A).
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of providing for the Assistant Secretary for Emer-
gency Preparedness and the operations of the National
System, other than purposes for which amounts in the
Public Health Emergency Fund under section 319 are
available, there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years 2002
through 2006.’’.
(b) SENSE OF CONGRESS REGARDING RESOURCES
OF NATIONAL SYSTEM.—It is the sense of the Congress
that the Secretary of Health and Human Services should
provide sufficient resources to individuals and entities
tasked to carry out the duties of the National Disaster
Medical System for reimbursement of expenses, oper-
ations, purchase and maintenance of equipment, training,
and other funds expended in furtherance of such National
System.
SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE
CONTROL AND PREVENTION WITH RESPECT
TO 
BIOTERRORISM 
AND 
OTHER 
PUBLIC
HEALTH EMERGENCIES; FACILITIES.
Section 319D of the Public Health Service Act (42
U.S.C. 247d–4) is amended to read as follows:
‘‘SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE
CONTROL AND PREVENTION.
‘‘(a) FINDINGS.—Congress finds that the Centers for
Disease Control and Prevention have an essential role in
defending against and combatting public health threats of
the 21st century and requires secure and modern facilities,
and expanded and improved capabilities related to biologi-
cal threats or attacks or other public health emergencies,
sufficient to enable such Centers to conduct this important
mission.
‘‘(b) IMPROVING THE CAPACITIES OF THE CENTERS
FOR DISEASE CONTROL AND PREVENTION.—
‘‘(1) IN
GENERAL.—The Secretary shall ex-
pand, enhance, and improve the capabilities of the
Centers for Disease Control and Prevention relating
to preparedness for and responding effectively to
bioterrorism and other public health emergencies.
Activities that may be carried out under the pre-
ceding sentence include—
‘‘(A) expanding or enhancing the training
of personnel;
‘‘(B) improving communications facilities
and networks;
‘‘(C) improving capabilities for public
health surveillance and reporting activities;
‘‘(D) improving laboratory facilities related
to bioterrorism, including increasing the secu-
rity of such facilities; and
‘‘(E) such other activities as the Secretary
determines appropriate.
‘‘(2) IMPROVING PUBLIC HEALTH LABORATORY
CAPACITY.—
‘‘(A) IN
GENERAL.—The Secretary, di-
rectly or through awards of grants, contracts,
or cooperative agreements, shall provide for the
establishment of a coordinated network of pub-
lic health laboratories, that may, at the discre-
tion of the Secretary, include laboratories that
serve as regional reference laboratories.
‘‘(B) PRIORITY.—In carrying out subpara-
graph (A), the Secretary shall give priority to
projects that include State or local government
financial commitments, that seek to incorporate
multiple public health and safety services or di-
agnostic databases into an integrated public
health or regional reference laboratory, and
that cover geographic areas lacking advanced
diagnostic and safety-level laboratory capabili-
ties.
‘‘(3) NATIONAL PUBLIC HEALTH COMMUNICA-
TIONS AND SURVEILLANCE NETWORK.—
‘‘(A) IN
GENERAL.—The Secretary, di-
rectly or through awards of grants, contracts,
or cooperative agreements, shall provide for the
establishment of integrated public health com-
munications and surveillance networks between
and among—
‘‘(i) Federal, State, and local public
health officials;
‘‘(ii) public and private health-related
laboratories, hospitals, and other health
care facilities; and
‘‘(iii) any other entities determined
appropriate by the Secretary.
‘‘(B) 
REQUIREMENTS.—The 
Secretary
shall ensure that networks under subparagraph
(A) allow for the timely sharing and discussion,
in a secure manner, of essential information
concerning a bioterrorist attack or other public
health emergency, or recommended methods for
responding to such an attack or emergency.
‘‘(4) CONTINUITY OF EFFORT.—To the max-
imum extent practicable, the Secretary, in con-
ducting activities under paragraphs (1) through (3),
shall administer such activities in a manner that in-
tensifies, expands, or enhances activities being car-
ried out on the date of enactment of this subsection.
‘‘(c) FACILITIES.—
‘‘(1) IN GENERAL.—The Director of the Cen-
ters for Disease Control and Prevention may design,
construct, and equip new facilities, renovate existing
facilities (including laboratories, laboratory support
buildings, scientific communication facilities, trans-
shipment complexes, secured and isolated parking
structures, office buildings, and other facilities and
infrastructure), and upgrade security of such facili-
ties, in order to better conduct the capacities de-
scribed in section 319A, and for supporting related
public health activities.
‘‘(2) MULTIYEAR CONTRACTING AUTHORITY.—
For any project of designing, constructing, equip-
ping, or renovating any facility under paragraph (1),
the Director of the Centers for Disease Control and
Prevention may enter into a single contract or re-
lated contracts that collectively include the full scope
of the project, and the solicitation and contract shall
contain the clause ‘availability of funds’ found at
section 52.232–18 of title 48, Code of Federal Regu-
lations.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) IN GENERAL.—For the purposes of achiev-
ing the mission of the Centers for Disease Control
and Prevention described in subsection (a), for car-
rying out subsection (b), for better conducting the
capacities described in section 319A, and for sup-
porting related public health activities, there are au-
thorized to be appropriated such sums as may be
necessary for each of the fiscal years 2002 through
2006.
‘‘(2) FACILITIES.—For the purpose of carrying
out subsection (c), there are authorized to be appro-
priated $300,000,000 for each of the fiscal years
2002 and 2003, and such sums as may be necessary
for each of the fiscal years 2004 through 2006.’’.
SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS.
Section 319F of the Public Health Service Act (42
U.S.C. 247d–6) is amended—
(1) by redesignating subsections (c) through (i)
as subsections (e) through (k), respectively; and
(2) by inserting after subsection (b) the fol-
lowing subsections:
‘‘(c) ADVICE TO THE FEDERAL GOVERNMENT.—
‘‘(1) REQUIRED
ADVISORY
COMMITTEES.—In
coordination with the working groups under sub-
sections (a) and (b), the Secretary shall establish ad-
visory committees in accordance with paragraphs (2)
and (3) to provide expert recommendations to assist
such working groups in carrying out their respective
responsibilities under subsections (a) and (b).
‘‘(2) NATIONAL
ADVISORY
COMMITTEE
ON
CHILDREN AND TERRORISM.—
‘‘(A) IN GENERAL.—For purposes of para-
graph (1), the Secretary shall establish an advi-
sory committee to be known as the National
Advisory Committee on Children and Terrorism
(referred to in this paragraph as the ‘Advisory
Committee’).
‘‘(B) DUTIES.—The Advisory Committee
shall provide recommendations regarding—
‘‘(i) the preparedness of the health
care (including mental health care) system
to respond to bioterrorism as it relates to
children;
‘‘(ii) needed changes to the health
care and emergency medical service sys-
tems and emergency medical services pro-
tocols to meet the special needs of children;
and
‘‘(iii) changes, if necessary, to the na-
tional stockpile under section 121 of the
Public Health Security and Bioterrorism
Response Act of 2001 to meet the special
needs of children.
‘‘(C) COMPOSITION.—The Advisory Com-
mittee shall be composed of such Federal offi-
cials as may be appropriate to address the spe-
cial needs of the diverse population groups of
children, and child health experts on infectious
disease, environmental health, toxicology, and
other relevant professional disciplines.
‘‘(D) TERMINATION.—The Advisory Com-
mittee terminates one year after the date of the
enactment of the Public Health Security and
Bioterrorism Response Act of 2001.
‘‘(3) EMERGENCY
PUBLIC
INFORMATION
AND
COMMUNICATIONS ADVISORY COMMITTEE.—
‘‘(A) IN GENERAL.—For purposes of para-
graph (1), the Secretary shall establish an advi-
sory committee to be known as the Emergency
Public Information and Communications Advi-
sory Committee (referred to in this paragraph
as the ‘EPIC Advisory Committee’).
‘‘(B) DUTIES.—The EPIC Advisory Com-
mittee shall make recommendations and report
on appropriate ways to communicate public-
health information regarding biological attacks
to the public.
‘‘(C) COMPOSITION.—The EPIC Advisory
Committee shall be composed of individuals rep-
resenting a diverse group of experts in public
health, communications, behavioral psychology,
and other areas determined appropriate by the
Secretary.
‘‘(D) 
DISSEMINATION.—The 
Secretary
shall ensure that the recommendations of the
EPIC Advisory Committee are widely dissemi-
nated to the media, State and local govern-
ments, poison control centers, and others as the
Secretary determines appropriate.
‘‘(E) TERMINATION.—The EPIC Advisory
Committee terminates one year after the date
of the enactment of the Public Health Security
and Bioterrorism Response Act of 2001.
‘‘(d) STRATEGY FOR COMMUNICATION OF INFORMA-
TION REGARDING BIOLOGICAL ATTACK.—In coordination
with the joint interdepartmental working group under sub-
section (b), the Secretary, acting through the Assistant
Secretary for Emergency Preparedness, shall develop a
strategy for effectively communicating information regard-
ing a biological attack, and shall develop means by which
to communicate such information. The Secretary may
carry out the preceding sentence directly or through
grants, contracts, or cooperative agreements.’’.
SEC. 105. EDUCATION OF HEALTH CARE PERSONNEL;
TRAINING REGARDING PEDIATRIC ISSUES.
Section 319F(g) of the Public Health Service Act, as
redesignated by section 104(1) of this Act, is amended to
read as follows:
‘‘(g) EDUCATION; TRAINING REGARDING PEDIATRIC
ISSUES.—
‘‘(1) MATERIALS; 
CORE
CURRICULUM.—The
Secretary, in collaboration with members of the
working group described in subsection (b), and pro-
fessional organizations and societies, shall—
‘‘(A) develop materials for teaching the ele-
ments of a core curriculum for the recognition
and identification (including proficiency testing)
of potential bioweapons and other agents that
may create a public health emergency, and for
the care of victims of such emergencies, recog-
nizing the special needs of children and other
vulnerable populations, to public health offi-
cials, medical professionals, emergency physi-
cians and other emergency department staff,
laboratory personnel, and other personnel work-
ing in health care facilities (including poison
control centers);
‘‘(B) develop a core curriculum and mate-
rials for community-wide planning by State and
local governments, hospitals and other health
care facilities, emergency response units, and
appropriate public and private sector entities to
respond to a bioterrorist attack or other public
health emergency;
‘‘(C) provide for dissemination and teach-
ing of the materials described in subparagraphs
(A) and (B) by all appropriate means, including
telemedicine, long-distance learning, or other
such means; and
‘‘(D) to the extent practicable, establish
and maintain an electronic database of individ-
uals participating in training or education pro-
grams carried out under this section, for the
purpose of providing continuing education ma-
terials and information to such participants.
‘‘(2) GRANTS.—In carrying out paragraph (1),
the Secretary may award grants to, or enter into co-
operative agreements with, professional organiza-
tions and societies, private accrediting organizations,
or other nonprofit institutions or entities meeting
criteria established by the Secretary, and may enter
into interagency cooperative agreements with other
Federal agencies.
‘‘(3) 
HEALTH-RELATED
ASSISTANCE
FOR
EMERGENCY RESPONSE PERSONNEL TRAINING.—
The Secretary, in consultation with the Attorney
General and the Director of the Federal Emergency
Management Agency, may provide assistance with
respect to health-related aspects of emergency re-
sponse personnel training carried out by the Depart-
ment of Justice and the Federal Emergency Man-
agement Agency.’’.
SEC. 106. GRANTS REGARDING SHORTAGES OF CERTAIN
HEALTH PROFESSIONALS.
Part B of title III of the Public Health Service Act
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 319G the following section:
‘‘SEC. 319H. GRANTS REGARDING TRAINING AND EDU-
CATION 
OF 
CERTAIN 
HEALTH 
PROFES-
SIONALS.
‘‘(a) IN GENERAL.—The Secretary may make awards
of grants and cooperative agreements to appropriate pub-
lic and nonprofit private health or educational entities, in-
cluding health professions schools and programs as de-
fined in section 799B, for the purpose of providing low-
interest loans, partial scholarships, partial fellowships, re-
volving loan funds, or other cost-sharing forms of assist-
ance for the education and training of individuals in any
category of health professions for which there is a shortage
that the Secretary determines should be alleviated in order
to prepare for or respond effectively to bioterrorism and
other public health emergencies.
‘‘(b) AUTHORITY REGARDING NON-FEDERAL CON-
TRIBUTIONS.—The Secretary may require as a condition
of an award under subsection (a) that a grantee under
such subsection provide non-Federal contributions toward
the purpose described in such subsection.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated such sums as may be necessary for
each of the fiscal years 2002 through 2006.’’.
SEC. 107. EMERGENCY SYSTEM FOR VERIFICATION OF CRE-
DENTIALS OF HEALTH PROFESSIONS VOLUN-
TEERS.
Part B of title III of the Public Health Service Act,
as amended by section 106 of this Act, is amended by in-
serting after section 319H the following section:
‘‘SEC. 319I. EMERGENCY SYSTEM FOR VERIFICATION OF
HEALTH PROFESSIONS VOLUNTEERS.
‘‘(a) IN GENERAL.—The Secretary shall, directly or
through an award of a grant, contract, or cooperative
agreement, establish and maintain a system for verifying
the credentials, licenses, accreditations, and hospital privi-
leges of individuals, who during public health emergencies
volunteer to serve as health professionals (referred to in
this section as the ‘verification system’). In carrying out
the preceding sentence, the Secretary shall provide for an
electronic database for the verification system.
‘‘(b) CERTAIN CRITERIA.—The Secretary shall estab-
lish criteria regarding the verification system under sub-
section (a), including provisions regarding the promptness
and efficiency of the system in collecting, storing, updat-
ing, and disseminating information on the credentials, li-
censes, accreditations, and hospital privileges of volunteers
described in subsection (a).
‘‘(c) ADVANCE REGISTRATION OF VOLUNTEERS.—In
order to facilitate the availability of health professionals
during a public health emergency, the Secretary shall pro-
vide for the advance registration with the system of health
professionals who are willing to serve as volunteers de-
scribed in subsection (a), and may carry out activities to
encourage health professionals to register with the system.
‘‘(d) OTHER ASSISTANCE.—The Secretary may make
grants and provide technical assistance to States and
other public or nonprofit private entities for activities re-
lating to the verification system developed under sub-
section (a).
‘‘(e) COORDINATION
AMONG
STATES.—The Sec-
retary shall encourage each State to provide legal author-
ity during a public health emergency for health profes-
sionals authorized in another State to provide certain
health services to provide such health services in the State.
‘‘(f) RULE OF CONSTRUCTION.—This section may
not be construed as authorizing the Secretary to issue re-
quirements regarding the provision by the States of cre-
dentials, licenses, accreditations, or hospital privileges.
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated $2,000,000 for fiscal year 2002, and
such sums as may be necessary for each of the fiscal years
2003 through 2006.’’.
SEC. 108. ENHANCING PREPAREDNESS ACTIVITIES FOR
BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES.
Section 319F of the Public Health Service Act (42
U.S.C. 247d–6) is amended—
(1) by amending subsection (a) to read as fol-
lows:
‘‘(a) WORKING GROUP ON PREPAREDNESS FOR ACTS
OF BIOTERRORISM.—The Secretary, in coordination with
the Secretary of Defense, the Director of the Federal
Emergency Management Agency, the Attorney General,
the Secretary of Veterans Affairs, the Secretary of Agri-
culture, the Secretary of Energy, and the Administrator
of the Environmental Protection Agency shall establish a
joint interdepartmental working group on preparedness
and readiness for the medical and public health effects of
a bioterrorist attack on the civilian population. Such joint
working group shall—
‘‘(1) coordinate and prioritize research on, and
the development of countermeasures against, patho-
gens likely to be used in a bioterrorist attack on the
civilian population;
‘‘(2) facilitate the development, production, and
regulatory review of priority countermeasures (as de-
fined in subsection (h)(2)(C)) for a bioterrorist at-
tack on the civilian population;
‘‘(3) coordinate research and development into
equipment to detect pathogens likely to be used in
a bioterrorist attack on the civilian population and
protect against infection from such pathogens;
‘‘(4) develop shared standards for equipment to
detect and to protect against infection from patho-
gens likely to be used in a bioterrorist attack on the
civilian population; and
‘‘(5) coordinate the development, maintenance,
and procedures for the release and distribution of
strategic reserves of vaccines, drugs, and medical
supplies which may be needed rapidly after a bioter-
rorist attack upon the civilian population, including
consideration of vulnerable populations (such as chil-
dren, the elderly, and individuals with disabilities).’’;
(2) in subsection (b)(1), by striking ‘‘The Sec-
retary’’ and all that follows through ‘‘shall establish’’
and inserting the following: ‘‘The Secretary, in col-
laboration with the Secretary of Defense, the Direc-
tor of the Federal Emergency Management Agency,
the Attorney General, the Secretary of Veterans Af-
fairs, the Secretary of Agriculture, the Secretary of
Labor, and the Administrator of the Environmental
Protection Agency, shall establish’’;
(3) in subsection (b)(2)—
(A) in subparagraph (A), by striking ‘‘re-
spond to a bioterrorist attack; and’’ and insert-
ing the following: ‘‘respond to a bioterrorist at-
tack, including the provision of appropriate
safety and health training and protective meas-
ures for medical, emergency service, and other
personnel responding to such attacks;’’;
(B) in subparagraph (B), by striking the
period and inserting ‘‘; and’’; and
(C) by adding at the end the following sub-
paragraph:
‘‘(C) subject to compliance with other pro-
visions of Federal law, clarify the responsibil-
ities among Federal officials for the investiga-
tion of suspicious outbreaks of disease, and re-
vise the interagency plan known as the Federal
response plan accordingly.’’;
(4) in subsection (b)(3), by striking ‘‘Assistant
Secretary for Health’’ and inserting ‘‘Assistant Sec-
retary for Emergency Preparedness’’; and
(5) in subsection (e) (as redesignated by section
104(1) of this Act)—
(A) in paragraph (1), by striking ‘‘The
Secretary’’ and all that follows and inserting
the following: ‘‘In consultation with the working
group established under subsection (b), the Sec-
retary shall, based on criteria established by the
Secretary, award grants to or enter into cooper-
ative agreements with eligible entities to in-
crease their capacity to detect, diagnose, and
respond to acts of bioterrorism upon the civilian
population.’’;
(B) in paragraph (2)—
(i) by striking ‘‘or’’ after ‘‘clinic,’’;
and
(ii) by inserting before the period the
following: ‘‘, professional organizations and
societies, schools or programs that train
medical laboratory personnel, private ac-
crediting organizations, or other nonprofit
institutions or entities meeting criteria es-
tablished by the Secretary’’;
(C) in paragraph (3)—
(i) in the matter preceding subpara-
graph (A), by striking ‘‘the priorities’’ and
inserting ‘‘any priorities’’; and
(ii) by striking subparagraphs (A)
through (D) and inserting the following:
‘‘(A) developing community-wide plans in-
volving the public and private health care infra-
structure to respond to bioterrorism or other
public health emergencies, which are coordi-
nated with the capacities of applicable national,
State, and local health agencies;
‘‘(B) training health care professionals and
public health personnel to enhance the ability of
such personnel to recognize the symptoms and
epidemiological characteristics of exposure to a
potential bioweapon, or other agents that may
cause a public health emergency;
‘‘(C) addressing rapid and accurate identi-
fication of potential bioweapons, or other agents
that may cause a public health emergency;
‘‘(D) coordinating medical care for individ-
uals during public health emergencies, including
bioterrorism;
‘‘(E) conducting exercises to test the capa-
bility and timeliness of public health emergency
response activities;
‘‘(F) facilitating and coordinating rapid
communication of data generated from a bioter-
rorist attack or public health emergency among
national, State, and local health agencies, emer-
gency response personnel, and health care pro-
viders and facilities; and
‘‘(G) purchasing or upgrading equipment,
supplies, pharmaceuticals or other counter-
measures to enhance preparedness for and re-
sponse to bioterrorism or other public health
emergencies, consistent with a plan described in
subparagraph (A).’’; and
(D) in paragraph (4)—
(i) in subparagraph (A), by striking
‘‘and’’ after the semicolon at the end;
(ii) in subparagraph (B), by striking
the period at the end and inserting ‘‘;
and’’; and
(iii) by adding at the end the fol-
lowing subparagraph:
‘‘(C) coordinate grants under this sub-
section with grants under 319C.’’.
SEC. 109. IMPROVING STATE AND LOCAL CORE PUBLIC
HEALTH CAPACITIES.
Section 319C of the Public Health Service Act (42
U.S.C. 247d–3) is amended—
(1) in subsection (a), by striking ‘‘competitive
’’; and
(2) in subsection (c)—
(A) in paragraph (3), by striking ‘‘health
care providers; and’’ and inserting ‘‘health care
providers, including poison control centers;’’;
(B) by redesignating paragraph (4) as
paragraph (7); and
(C) by inserting after paragraph (3) the
following paragraphs:
‘‘(4) purchase or upgrade equipment, supplies,
pharmaceuticals or other countermeasures to en-
hance preparedness for and response to bioterrorism
or other public health emergencies, consistent with a
plan described in paragraph (3);
‘‘(5) conduct exercises to test the capability and
timeliness of public health emergency response ac-
tivities;
‘‘(6) within the meaning of part B of title XII,
develop and implement the trauma care component
of the State plan for the provision of emergency
medical services; and’’;
SEC. 110. ANTIMICROBIAL RESISTANCE PROGRAM.
Section 319E of the Public Health Service Act (42
U.S.C. 247d–5) is amended—
(1) in subsection (b)—
(A) by striking ‘‘shall conduct and sup-
port’’ and inserting ‘‘shall directly or through
awards of grants or cooperative agreements to
public or private entities provide for the con-
duct of’’; and
(B) by amending paragraph (4) to read as
follows:
‘‘(4) the sequencing of the genomes, or other
appropriate DNA analysis, or other necessary com-
parative analysis, of priority pathogens (as deter-
mined by the Director of the National Institutes of
Health in consultation with the task force estab-
lished under subsection (a)), in collaboration and co-
ordination with the activities of the Department of
Defense and the Joint Genome Institute of the De-
partment of Energy; and’’;
(2) in subsection (e)(2), by inserting after ‘‘so-
cieties,’’ the following: ‘‘schools or programs that
train medical laboratory personnel,’’; and
(3) in subsection (g), by striking ‘‘and such
sums’’ and all that follows and inserting the fol-
lowing: ‘‘$25,000,000 for each of the fiscal years
2002 and 2003, and such sums as may be necessary
for each of the fiscal years 2004 through 2006.’’.
SEC. 111. STUDY REGARDING COMMUNICATIONS ABILITIES
OF PUBLIC HEALTH AGENCIES.
The Secretary of Health and Human Services, in con-
sultation with the Federal Communications Commission,
the National Telecommunications and Information Ad-
ministration, and other appropriate Federal agencies,
shall conduct a study to ensure that local public health
entities have the ability to maintain communications in the
event of a bioterrorist attack or other public health emer-
gency. The study shall examine whether redundancies are
required in the telecommunications system for public
health entities to maintain systems operability and
connectivity during such emergencies. The study shall also
include recommendations to industry and public health en-
tities about how to implement such redundancies if nec-
essary.
SEC. 112. SUPPLIES AND SERVICES IN LIEU OF AWARD
FUNDS.
Part B of title III of the Public Health Service Act,
as amended by section 107 of this Act, is amended by in-
serting after section 319I the following section:
‘‘SEC. 319J. SUPPLIES AND SERVICES IN LIEU OF AWARD
FUNDS
‘‘(a) IN GENERAL.—Upon the request of a recipient
of an award under any of sections 319 through 319I or
section 319K, the Secretary may, subject to subsection
(b), provide supplies, equipment, and services for the pur-
pose of aiding the recipient in carrying out the purposes
for which the award is made and, for such purposes, may
detail to the recipient any officer or employee of the De-
partment of Health and Human Services.
‘‘(b) CORRESPONDING REDUCTION IN PAYMENTS.—
With respect to a request described in subsection (a), the
Secretary shall reduce the amount of payments under the
award involved by an amount equal to the costs of detail-
ing personnel and the fair market value of any supplies,
equipment, or services provided by the Secretary. The Sec-
retary shall, for the payment of expenses incurred in com-
plying with such request, expend the amounts withheld.’’.
SEC. 113. ADDITIONAL AMENDMENTS.
Part B of title III of the Public Health Service Act
(42 U.S.C. 243 et seq) is amended—
(1) in section 319A(a)(1), by striking ‘‘10
years’’ and inserting ‘‘five years’’; and
(2) in section 319B(a), in the first sentence, by
striking ‘‘10 years’’ and inserting ‘‘five years’’.
SEC. 114. STUDY REGARDING LOCAL EMERGENCY RE-
SPONSE METHODS.
The Secretary of Health and Human Services shall
conduct a study of best-practices methods for the provi-
sion of emergency response services through local govern-
ments (including through contractors and volunteers of
such governments) in a consistent manner in response to
acts of bioterrorism or other public health emergencies.
Not later than 180 days after the date of the enactment
of this Act, the Secretary shall submit to the Congress
a report describing the findings of the study.
Subtitle B—National Stockpile; De-
velopment of Priority Counter-
measures
SEC. 121. NATIONAL STOCKPILE.
(a) IN GENERAL.—The Secretary of Health and
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall maintain a stockpile or stockpiles of drugs,
vaccines and other biological products, medical devices,
and other supplies in such numbers, types, and amounts
as are determined by the Secretary to be adequate to meet
the health security needs of the United States, including
consideration of vulnerable populations (such as children,
the elderly, and individuals with disabilities), in the event
of a bioterrorist attack or other public health emergency.
(b) PROCEDURES.—The Secretary, in managing the
stockpile under subsection (a), shall—
(1) consult with the Director of the Federal
Emergency Management Agency, the Secretary of
Defense, the Secretary of Veterans Affairs, the At-
torney General, the Secretary of Energy, and the
Administrator of the Environmental Protection
Agency;
(2) ensure that adequate procedures are fol-
lowed with respect to such stockpile for inventory
management and accounting, and for the physical
security of the stockpile;
(3) in consultation with Federal, State, and
local officials, take into consideration the timing and
location of special events;
(4) review and revise, as appropriate, the con-
tents of the stockpile on a regular basis to ensure
that emerging threats, advanced technologies, and
new countermeasures are adequately considered; and
(5) devise plans for the effective and timely dis-
tribution of the stockpile, in consultation with appro-
priate Federal, State and local agencies, and the
public and private health care infrastructure.
(c) DEFINITION.—For purposes of subsection (a), the
term ‘‘stockpile’’ includes—
(1) a physical accumulation (at one or more lo-
cations) of the supplies described in subsection (a);
or
(2) a contractual agreement between the Sec-
retary and a vendor or vendors under which such
vendor or vendors agree to provide to the Secretary
supplies described in subsection (a).
(d) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated $1,155,000,000 for fiscal year 2002,
and such sums as may be necessary for each of fiscal years
2003 through 2006.
SEC. 122. ACCELERATED APPROVAL OF PRIORITY COUN-
TERMEASURES.
(a) IN GENERAL.—The Secretary of Health and
Human Services may designate a priority countermeasure
as a fast-track product pursuant to section 506 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356).
Such a designation may be made prior to the submission
of—
(1) a request for designation by the sponsor; or
(2) an application for the investigation of the
drug under section 505(i) of such Act or section
351(a)(3) of the Public Health Service Act. Nothing
in this subsection shall be construed to prohibit a
sponsor from declining such a designation.
(b) REVIEW OF PRIORITY COUNTERMEASURE NOT
DESIGNATED
AS
FAST-TRACK
PRODUCT.—A priority
countermeasure shall be subject to the performance goals
established by the Commissioner of Food and Drugs, un-
less it is designated as a fast-track product.
(c) DEFINITION.—For purposes of this section, the
term ‘‘priority countermeasure’’ means a drug or biologi-
cal product that is a countermeasure to treat, identify, or
prevent infection by a biological agent or toxin listed pur-
suant to section 351A(a)(1) or harm from any other agent
that may cause a public health emergency.
SEC. 123. USE OF ANIMAL TRIALS IN APPROVAL OF CER-
TAIN DRUGS AND BIOLOGICS; ISSUANCE OF
RULE.
Not later than 180 days after the date of the enact-
ment of this Act, the Secretary of Health and Human
Services shall complete the process of rulemaking that was
commenced with the issuance of the proposed rule entitled
‘‘New Drug and Biological Drug Products; Evidence
Needed to Demonstrate Efficacy of New Drugs for Use
Against Lethal or Permanently Disabling Toxic Sub-
stances When Efficacy Studies in Humans Ethically Can-
not be Conducted’’ published in the Federal Register on
October 5, 1999 (64 Fed. Reg. 53960).
SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOP-
MENT AND PRODUCTION.
Part B of title III of the Public Health Service Act,
as amended by section 112 of this Act, is amended by in-
serting after section 319J the following section:
‘‘SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOP-
MENT AND PRODUCTION.
‘‘The Secretary, in consultation with the Attorney
General and the Secretary of Defense, may provide tech-
nical or other assistance to provide security to persons or
facilities that conduct development, production, distribu-
tion, or storage of priority countermeasures (as defined
in section 319F(h)(2)(C)).’’.
SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH
AND DEVELOPMENT.
Section 319F(h) of the Public Health Service Act, as
redesignated by section 104(1) of this Act, is amended—
(1) by redesignating paragraphs (1) through
(4), as subparagraphs (A) through (D), respectively;
(2) by striking ‘‘The Secretary’’ and inserting
the following:
‘‘(1) IN GENERAL.—The Secretary’’;
(3) by moving each of subparagraphs (A)
through (D) (as so redesignated) two ems to the
right; and
(4) by adding at the end the following:
‘‘(2) ACCELERATED
COUNTERMEASURE
RE-
SEARCH AND DEVELOPMENT.—
‘‘(A) IN GENERAL.—With respect to patho-
gens of potential use in a bioterrorist attack,
and other agents that may cause a public
health emergency, the Secretary, taking into
consideration any recommendations of the
working group under subsection (a), shall con-
duct, and award grants, contracts, or coopera-
tive agreements for, research, investigations, ex-
periments, demonstrations, and studies in the
health sciences relating to—
‘‘(i) the epidemiology and patho-
genesis of such pathogens;
‘‘(ii) the development of new vaccines
and therapeutics for use against such
pathogens and other agents;
‘‘(iii) the development of diagnostic
tests to detect such pathogens and other
agents; and
‘‘(iv) other relevant areas of research;
with consideration given to the needs of chil-
dren and other vulnerable populations.
‘‘(B) ROLE
OF
DEPARTMENT
OF
VET-
ERANS
AFFAIRS.—In carrying out subpara-
graph (A), the Secretary shall consider using
the biomedical research and development capa-
bilities of the Department of Veterans Affairs,
in conjunction with that Department’s affili-
ations 
with 
health-professions 
universities.
When advantageous to the Government in fur-
therance of the purposes of such subparagraph,
the Secretary may enter into cooperative agree-
ments with the Secretary of Veterans Affairs to
achieve such purposes.
‘‘(C) PRIORITY COUNTERMEASURES.—For
purposes of this paragraph, the term ‘priority
countermeasure’ means a countermeasure, in-
cluding a drug, medical or other technological
device, biological product, or diagnostic test, to
treat, identify, or prevent infection by a biologi-
cal agent or toxin listed pursuant to section
351A(a)(1) or harm from any other agent that
may cause a public health emergency.’’.
SEC. 126. EVALUATION OF NEW AND EMERGING TECH-
NOLOGIES REGARDING BIOTERRORIST AT-
TACK AND OTHER PUBLIC HEALTH EMER-
GENCIES.
(a) IN GENERAL.—The Secretary of Health and
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall promptly carry out a program to evaluate
new and emerging technologies that are designed to im-
prove or enhance the ability of public health or safety offi-
cials to detect, identify, diagnose, or conduct public health
surveillance activities relating to a bioterrorist attack or
other public health emergency.
(b) CERTAIN ACTIVITIES.—In carrying out this sub-
section, the Secretary shall—
(1) survey existing technology programs funded
by the Federal Government for potentially useful
technologies;
(2) promptly issue a request for information
from non-Federal public and private entities for on-
going activities in this area; and
(3) evaluate technologies identified under para-
graphs (1) and (2) pursuant to subsection (c).
(c) CONSULTATION AND EVALUATION.—In carrying
out subsection (b)(3), the Secretary shall consult with the
joint interdepartmental working group under section
319F(a) of the Public Health Service Act, as well as other
appropriate public, nonprofit, and private entities, to de-
velop criteria for the evaluation of such technologies and
to conduct such evaluations.
(d) REPORT.—Not later than 180 days after the date
of the enactment of this Act, the Secretary shall submit
to the Committee on Energy and Commerce of the House
of Representatives, and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, a report that
provides a list of priority technologies whose development
or deployment or both should be accelerated, and the esti-
mated cost of doing so.
SEC. 127. POTASSIUM IODIDE.
(a) IN GENERAL.—Through the national stockpile
under section 121, the Secretary of Health and Human
Services (in this section referred to as the ‘‘Secretary’’),
subject to subsection (b), shall make available to State and
local governments potassium iodide tablets for stockpiling
and for distribution as appropriate to public facilities,
such as schools and hospitals, that are within 20 miles
of a nuclear power plant, in quantities sufficient to provide
adequate protection for the populations within such miles.
(b) STATE AND LOCAL PLANS.—Subsection (a) ap-
plies with respect to a State or local government if the
government involved meets the following conditions:
(1) Such government submits to the Secretary,
and to the Director of the Federal Emergency Man-
agement Agency, a plan for the stockpiling of potas-
sium iodide tablets, and for the distribution and uti-
lization of potassium iodide tablets in the event of
a nuclear incident.
(2) The plan is accompanied by certifications by
such government that—
(A) the government has not received suffi-
cient quantities of potassium iodide tablets from
the Nuclear Regulatory Commission; and
(B) in the case of a local government, such
government has submitted the plan to the State
involved.
(c) GUIDELINES.—In consultation with the Director
of the Federal Emergency Management Agency and with
the Nuclear Regulatory Commission, the Secretary shall
establish guidelines for the stockpiling of potassium iodide
tablets, and for the distribution and utilization of potas-
sium iodide tablets in the event of a nuclear incident.
(d) INFORMATION.—The Secretary shall carry out ac-
tivities to inform State and local governments of the pro-
gram under this section.
(e) REPORT.—Not later than six months after the
date of the enactment of this Act, the Secretary shall sub-
mit to the Congress a report—
(1) on whether potassium iodide tablets have
been made available under subsection (a) and the ex-
tent to which State and local governments have es-
tablished stockpiles of such tablets; and
(2) the measures taken by the Secretary to implement
this section.
(f) APPLICABILITY.—Subsections (a) and (d) cease to
apply as requirements if the Secretary determines that
there is an alternative and more effective medical treat-
ment to address adverse thyroid conditions that may re-
sult from the release of radionuclides from nuclear power
plants.
Subtitle C—Emergency Authorities;
Additional Provisions
SEC. 131. EXPANDED AUTHORITY OF SECRETARY OF
HEALTH AND HUMAN SERVICES TO RESPOND
TO PUBLIC HEALTH EMERGENCIES.
(a) TRANSFERS OF FUNDS.—Section 319 of the Pub-
lic Health Service Act (42 U.S.C. 247d) is amended by
adding at the end the following:
‘‘(d) TRANSFERS OF FUNDS BETWEEN PROGRAMS
AND ACCOUNTS.—
‘‘(1) IN GENERAL.—At any time during a pub-
lic health emergency declared by the Secretary under
subsection (a), the Secretary may, subject to para-
graph (2), transfer funds, to the extent authorized
by law, between appropriations accounts adminis-
tered by the Secretary under this Act, without re-
gard to any waiting period imposed by any other
provision of law, including any provision of an ap-
propriations Act, except as provided in paragraphs
(3) and (4).
‘‘(2) AMOUNT OF TRANSFERS.—With respect to
the public health emergency involved:
‘‘(A) The Secretary may not make a trans-
fer under paragraph (1) in an amount exceed-
ing a reasonable estimate by the Secretary of
the amount necessary to respond to the emer-
gency involved for a period of 60 days.
‘‘(B) Subsequent transfers under para-
graph (1) may be made by the Secretary, sub-
ject to compliance with subparagraph (A).
‘‘(3) NOTIFICATION.—Not later than 48 hours
prior to making a transfer under paragraph (1), the
Secretary shall submit a notice of the intent to make
such transfer to the Committee on Appropriations of
the House of Representatives, the Committee on En-
ergy and Commerce of the House of Representa-
tives, the Committee on Appropriations of the Sen-
ate, and the Committee on Health, Education,
Labor, and Pensions of the Senate.
‘‘(4) SCOPE.—Paragraph (1) shall apply, not-
withstanding any other provision of law including
any provision of an appropriations Act and any Act
enacted after the date of enactment of this sub-
section, unless such provision specifically refers to
and overrides this subsection.’’.
(b) REPORTING DEADLINES.—Section 319 of the
Public Health Service Act (42 U.S.C. 247d), as amended
by subsection (a), is further amended by adding at the
end the following:
‘‘(e) DATA SUBMITTAL
AND REPORTING DEAD-
LINES.—In any case in which the Secretary determines
that, wholly or partially as a result of a public health
emergency that has been declared pursuant to subsection
(a), individuals or public or private entities are unable to
comply with deadlines for the submission to the Secretary
of data or reports required under any law administered
by the Secretary, the Secretary may, notwithstanding any
other provision of law, grant such extensions of such dead-
lines as the circumstances reasonably require, and may
waive, wholly or partially, any sanctions otherwise applica-
ble to such failure to comply. Before or promptly after
granting such an extension or waiver, the Secretary shall
notify the Congress of such action and publish in the Fed-
eral Register a notice of the extension or waiver.’’.
SEC. 
132. 
STREAMLINING 
AND 
CLARIFYING 
COMMU-
NICABLE DISEASE QUARANTINE PROVISIONS.
(a) ELIMINATION OF PREREQUISITE FOR NATIONAL
ADVISORY HEALTH COUNCIL RECOMMENDATION BEFORE
ISSUING QUARANTINE RULES.—
(1) EXECUTIVE ORDERS SPECIFYING DISEASES
SUBJECT
TO
INDIVIDUAL
DETENTIONS.—Section
361(b) of the Public Health Act (42 U.S.C. 264(b))
is amended by striking ‘‘Executive orders of the
President upon the recommendation of the National
Advisory Health Council and the Surgeon General’’
and inserting ‘‘Executive orders of the President
upon the recommendation of the Secretary, in con-
sultation with the Surgeon General,’’.
(2) REGULATIONS PROVIDING FOR APPREHEN-
SION OF INDIVIDUALS.—Section 361(d) of the Pub-
lic Health Act (42 U.S.C. 264(d)) is amended by
striking ‘‘On recommendation of the National Advi-
sory Health Council, regulations’’ and inserting
‘‘Regulations’’.
(3) REGULATIONS PROVIDING FOR APPREHEN-
SION OF INDIVIDUALS IN WARTIME.—Section 363 of
the Public Health Act (42 U.S.C. 266) is amended
by striking ‘‘the Surgeon General, on recommenda-
tion of the National Advisory Health Council,’’ and
inserting ‘‘the Secretary, in consultation with the
Surgeon General,’’.
(b) APPREHENSION AUTHORITY TO APPLY IN CASES
OF EXPOSURE TO DISEASE.—
(1) REGULATIONS PROVIDING FOR APPREHEN-
SION OF INDIVIDUALS.—Section 361(d) of the Pub-
lic Health Act (42 U.S.C. 264(d)), as amended by
subsection (a)(2), is further amended by inserting
‘‘or exposed to’’ after ‘‘to be infected with’’.
(2) REGULATIONS PROVIDING FOR APPREHEN-
SION OF INDIVIDUALS IN WARTIME.—Section 363 of
the Public Health Act (42 U.S.C. 266), as amended
by subsection (a)(3), is further amended by inserting
‘‘or exposed to’’ after ‘‘to be infected with’’.
(c) STATE AUTHORITY.—Section 361 of the Public
Health Act (42 U.S.C. 264) is amended by adding at the
end the following:
‘‘(e) Nothing in this section or section 363, or the
regulations promulgated under such sections, may be con-
strued as superseding any provision under State law (in-
cluding regulations and including provisions established by
political subdivisions of States), except to the extent that
such a provision conflicts with an exercise of Federal au-
thority under this section or section 363.’’.
SEC. 133. EMERGENCY WAIVER OF MEDICARE, MEDICAID,
AND SCHIP REQUIREMENTS.
(a) WAIVER AUTHORITY.—Title XI of the Social Se-
curity Act (42 U.S.C. 1301 et seq.) is amended by insert-
ing after section 1134 the following new section:
‘‘SEC. 1135. AUTHORITY TO WAIVE REQUIREMENTS DURING
NATIONAL EMERGENCIES.
‘‘(a) PURPOSE.—
‘‘(1) IN GENERAL.—The purpose of this section
is to enable the Secretary to ensure to the maximum
extent feasible, in any emergency area and during an
emergency period—
‘‘(A) that sufficient health care items and
services are available to meet the needs of indi-
viduals in such area enrolled in the programs
under titles XVIII, XIX, and XXI; and
‘‘(B) that health care providers (as defined
in subsection (g)) that furnish such items and
services in good faith, but that are unable to
comply with one or more requirements de-
scribed in subsection (b), may be reimbursed
for such items and services and exempted from
sanctions for such noncompliance, absent any
determination of fraud or abuse.
‘‘(2) EMERGENCY
AREA; 
EMERGENCY
PE-
RIOD.—For purposes of this section, an ‘emergency
area’ is a geographical area in which, and an ‘emer-
gency period’ is the period during which, there
exists—
‘‘(A) an emergency or disaster declared by
the President pursuant to the National Emer-
gencies Act or the Robert T. Stafford Disaster
Relief and Emergency Assistance Act; and
‘‘(B) a public health emergency declared
by the Secretary pursuant to section 319 of the
Public Health Service Act.
‘‘(b) SECRETARIAL AUTHORITY.—To the extent nec-
essary to accomplish the purposes specified in subsection
(a), the Secretary is authorized, subject to the provisions
of this section, to temporarily waive or modify the applica-
tion of, with respect to health care items and services fur-
nished in any emergency area (or portion of such an area)
during an emergency period, the requirements of titles
XVIII, XIX, or XXI, or any regulation thereunder (and
the requirements of this title, and regulations thereunder,
insofar as they relate to such titles), pertaining to—
‘‘(1) conditions of participation or other certifi-
cation requirements for an individual health care
provider or types of providers; program participation
and similar requirements for an individual health
care provider or types of providers; and pre-approval
requirements;
‘‘(2) requirements that physicians and other
health care professionals be licensed in the State in
which they provide such services, if they have equiv-
alent licensing in another State;
‘‘(3) sanctions under section 1867 (relating to
examination and treatment for emergency medical
conditions and women in labor) for a transfer of an
individual who has not been stabilized in violation of
subsection (c) of such section if the transfer arises
out of the circumstances of the emergency;
‘‘(4) sanctions under section 1877(g) (relating
to limitations on physician referral); and
‘‘(5) deadlines and timetables for performance
of required activities, except that such deadlines and
timetables may only be modified, not waived.
‘‘(c) AUTHORITY
FOR RETROACTIVE WAIVER.—A
waiver or modification of requirements pursuant to this
section may, at the Secretary’s discretion, be made retro-
active to the beginning of the emergency period or any
subsequent date in such period specified by the Secretary.
‘‘(d) NOTIFICATION OF CONGRESS.—The Secretary
shall provide advance written notice to the Congress at
least two days before exercising the authority under this
section with respect to an emergency area. Such a notice
shall include a description of the specific provisions that
will be waived or modified, the health care providers to
whom the waiver or modification will apply, the geographic
area in which the waiver or modification will apply, and
the period of time for which the waiver or modification
will be in effect.
‘‘(e) DURATION OF WAIVER.—
‘‘(1) IN GENERAL.—A waiver or modification of
requirements pursuant to this section terminates
upon—
‘‘(A) the termination of the applicable dec-
laration of emergency or disaster described in
subsection (a)(2)(B);
‘‘(B) the termination of the applicable dec-
laration of public health emergency described in
subsection (a)(2)(B); or
‘‘(C) subject to paragraph (2), the termi-
nation of a period of 90 days from the date the
waiver or modification is first published (or, if
applicable, the date of extension of the waiver
or modification under paragraph (2)).
‘‘(2) EXTENSION
OF
90-DAY
PERIODS.—The
Secretary may, by notice, provide for an extension of
a 90-day period described in paragraph (1)(C) (or
an additional period provided under this paragraph)
for additional period or periods (not to exceed, ex-
cept as subsequently provided under this paragraph,
90 days each), but any such extension shall not af-
fect or prevent the termination of a waiver or modi-
fication under subparagraph (A) or (B) of para-
graph (1).
‘‘(f) REPORT TO CONGRESS.—Within one year after
the end of the emergency period in an emergency area in
which the Secretary exercised the authority provided
under this section, the Secretary shall report to the Con-
gress regarding the approaches used to accomplish the
purposes described in subsection (a), including an evalua-
tion of the success of such approaches and recommenda-
tions for improved approaches should the need for such
emergency authority arise in the future.
‘‘(g) HEALTH CARE PROVIDER DEFINED.—For pur-
poses of this section, the term ‘health care provider’ means
any entity that furnishes health care items or services, and
includes a hospital or other provider of services, a physi-
cian or other health care practitioner or professional, a
health care facility, or a supplier of health care items or
services.’’.
(b) EFFECTIVE DATE.—The amendments made by
subsection (a) shall be effective on and after September
11, 2001.
SEC. 134. PROVISION FOR EXPIRATION OF PUBLIC HEALTH
EMERGENCIES.
Section 319(a) of the Public Health Service Act (42
U.S.C. 247d(a)), is amended by adding at the end the fol-
lowing new sentence: ‘‘Any such determination of a public
health emergency terminates upon the Secretary declaring
that the emergency no longer exists, or upon the expira-
tion of the 90-day period beginning on the date on which
the determination is made by the Secretary, whichever oc-
curs first. Determinations that terminate under the pre-
ceding sentence may be renewed by the Secretary (on the
basis of the same or additional facts), and the preceding
sentence applies to each such renewal.’’.
SEC. 135. DESIGNATED STATE PUBLIC EMERGENCY AN-
NOUNCEMENT PLAN.
Section 613(b) of the Robert T. Stafford Disaster Re-
lief and Emergency Assistance Act (42 U.S.C. 5196b(b))
is amended—
(1) in paragraph (5), by striking ‘‘and’’ at the
end;
(2) in paragraph (6), by striking the period and
inserting ‘‘; and’’; and
(3) by adding at the end the following:
‘‘(7) include a plan for providing information to
the public in a coordinated manner.’’.
SEC. 136. EXPANDED RESEARCH BY SECRETARY OF EN-
ERGY.
(a) IN GENERAL.—In coordination with the joint
interdepartmental working group under section 319F(a)
of the Public Health Service Act, the Secretary of Energy
and the Administrator of the National Nuclear Security
Administration shall expand, enhance, and intensify re-
search relevant to the rapid detection and identification
of pathogens likely to be used in a bioterrorism attack or
other agents that may cause a public health emergency.
(b) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section
such sums as may be necessary for each of the fiscal years
2002 through 2006.
SEC. 137. AGENCY FOR TOXIC SUBSTANCES AND DISEASE
REGISTRY.
(a) IN GENERAL.—In planning for and responding
to bioterrorism and other public health emergencies, in-
cluding assisting State health departments, the Secretary
of Health and Human Services (in this section referred
to as the ‘‘Secretary’’) shall take into account the role and
expertise of the Agency for Toxic Substances and Disease
Registry (in this section referred to as ‘‘ATSDR’’).
(b) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of providing resources (including increased per-
sonnel, as appropriate) for ATSDR to use authorities
under section 104(i) of the Comprehensive Environmental
Response, Compensation, and Liability Act of 1980 to as-
sist the Secretary in planning for or responding to bioter-
rorism or other public health emergencies, there are au-
thorized to be appropriated to the Secretary such sums
as may be necessary for each of the fiscal years 2002
through 2006, in addition to any other authorizations of
appropriations that are available for such purpose.
SEC. 138. EXPANDED RESEARCH ON WORKER HEALTH AND
SAFETY.
The Secretary, acting through the Director of the Na-
tional Institute of Occupational Safety and Health, shall
enhance and expand research as deemed appropriate on
the health and safety of workers who are at risk for bioter-
rorist threats or attacks in the workplace.
SEC. 139. TECHNOLOGY OPPORTUNITIES PROGRAM SUP-
PORT.
For fiscal years 2003 and 2004, all of the informa-
tion infrastructure grants provided by the National Tele-
communications and Information Administration (under
the program also known as the Technology Opportunities
Program) shall be used to provide grants to health pro-
viders to facilitate participation in the national public
health communications and surveillance networks author-
ized under section 319D(b)(3) of the Public Health Serv-
ice Act.
Subtitle D—Authorization of
Appropriations
SEC. 151. AUTHORIZATION OF APPROPRIATIONS.
(a) IN GENERAL.—For the purpose of carrying out
activities of the Department of Health and Human Serv-
ices in accordance with the provisions referred to in sub-
section (b), including making awards of grants, coopera-
tive agreements, or contracts and providing other assist-
ance to States and other public or private entities, there
are authorized to be appropriated $2,720,000,000 for fis-
cal year 2002, and such sums as may be necessary for
each of the fiscal years 2003 through 2006.
(b) RELEVANT PROVISIONS.—For purposes of this
section, the provisions referred to in this subsection are—
(1) the provisions of this title;
(2) sections 319A through 319K of the Public
Health Service Act;
(3) title XXVIII of such Act; and
(4) section 301 of such Act, to the extent that
such section is used as the authority of the Sec-
retary of Health and Human Services to carry out
activities to supplement the activities carried out
under the provisions referred to in paragraphs (1)
through (3);
except that this section does not have any applicability
with respect to the use of section 301 of such Act as au-
thority for activities of the National Institutes of Health.
(c) FISCAL YEAR 2002.—
(1) IN
GENERAL.—The aggregate amount of
authorizations of appropriations under this title and
under the Public Health Service Act for fiscal year
2002 for the purpose described in subsection (a)
does not exceed the amount specified for fiscal year
2002 in such subsection, notwithstanding other au-
thorizations of appropriations.
(2) ALLOCATIONS
OF
AUTHORIZATIONS.—Of
the amount that is authorized to be appropriated
under subsection (a) for fiscal year 2002, the fol-
lowing authorizations of appropriations for such fis-
cal year for the purpose described in such subsection
apply:
(A) For making awards of grants, coopera-
tive agreements, or contracts and providing
other assistance to States and other public or
private entities, $1,000,000,000 is authorized,
of which—
(i) $455,000,000 is authorized for
grants under section 319C of the Public
Health Service Act;
(ii) $455,000,000 is authorized for
grants or cooperative agreements under
section 319F of such Act; and
(iii) $40,000,000 is authorized for
grants or cooperative agreements under
section 319H of the Public Health Service
Act, as added by section 106 of this Act
(relating to shortages of certain health pro-
fessionals).
(B) For the national stockpile under sec-
tion 121 of this Act, other than activities of the
National Institutes of Health regarding small-
pox vaccine, $1,155,000,000 is authorized, of
which $509,000,0000 is authorized for the ac-
quisition of smallpox vaccine.
(C) For the Centers for Disease Control
and Prevention, other than purposes to which
the authorization established in subparagraph
(A) 
applies, 
$450,000,000, 
of 
which
$300,000,000 is authorized for facilities of such
Centers for purposes described in section
399D(c) of the Public Health Service Act.
(D) For activities on antimicrobial resist-
ance 
under 
section 
319E 
of 
such 
Act,
$25,000,000 is authorized.
TITLE 
II—ENHANCING 
CON-
TROLS ON DANGEROUS BIO-
LOGICAL AGENTS AND TOX-
INS
SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS
AND TOXINS.
(a) BIOLOGICAL
AGENTS
PROVISIONS
OF
THE
ANTITERRORISM AND EFFECTIVE DEATH PENALTY ACT
OF 1996; CODIFICATION IN THE PUBLIC HEALTH SERV-
ICE ACT, WITH AMENDMENTS.—
(1) PUBLIC HEALTH SERVICE ACT.—Subpart 1
of part F of title III of the Public Health Service
Act (42 U.S.C. 262 et seq.) is amended by inserting
after section 351 the following:
‘‘SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGI-
CAL AGENTS AND TOXINS.
‘‘(a) REGULATORY CONTROL OF CERTAIN BIOLOGI-
CAL AGENTS AND TOXINS.—
‘‘(1) LIST OF BIOLOGICAL AGENTS AND TOX-
INS.—
‘‘(A) IN GENERAL.—The Secretary shall by
regulation establish and maintain a list of each
biological agent and each toxin that has the po-
tential to pose a severe threat to public health
and safety.
‘‘(B) CRITERIA.—In determining whether
to include an agent or toxin on the list under
subparagraph (A), the Secretary shall—
‘‘(i) consider—
‘‘(I) the effect on human health
of exposure to the agent or toxin;
‘‘(II) the degree of contagious-
ness of the agent or toxin and the
methods by which the agent or toxin
is transferred to humans;
‘‘(III) the availability and effec-
tiveness of immunizations to prevent
and treatments for any illness result-
ing from infection by the agent or
toxin; and
‘‘(IV) any other criteria that the
Secretary considers appropriate; and
‘‘(ii) consult with scientific experts
representing 
appropriate 
professional
groups.
‘‘(2) BIENNIAL PUBLICATION.—The Secretary
shall publish the list under paragraph (1) biennially,
or at such more frequent intervals as the Secretary
determines to be appropriate. Before publishing the
list, the Secretary shall review the list, and shall
make such revisions as are appropriate to protect
the public health and safety. In reviewing and revis-
ing the list, the Secretary shall consider the needs
of vulnerable populations, including children, and
shall consult with appropriate Federal agencies and
State and local public health officials.
‘‘(b) REGULATION OF TRANSFERS OF LISTED BIO-
LOGICAL AGENTS AND TOXINS.—The Secretary shall by
regulation provide for—
‘‘(1) the establishment and enforcement of safe-
ty procedures for the transfer of biological agents
and toxins listed pursuant to subsection (a)(1), in-
cluding measures to ensure—
‘‘(A) proper training and appropriate skills
to handle such agents and toxins; and
‘‘(B) proper laboratory facilities to contain
and dispose of such agents and toxins;
‘‘(2) safeguards to prevent access to such
agents and toxins for use in domestic or inter-
national terrorism or for any other criminal purpose;
‘‘(3) the establishment of procedures to protect
the public safety in the event of a transfer or poten-
tial transfer of a biological agent or toxin in viola-
tion of the safety procedures established under para-
graph (1) or the safeguards established under para-
graph (2); and
‘‘(4) appropriate availability of biological agents
and toxins for research, education, and other legiti-
mate purposes.
‘‘(c) POSSESSION AND USE OF LISTED BIOLOGICAL
AGENTS AND TOXINS.—The Secretary shall by regulation
provide for the establishment and enforcement of stand-
ards and procedures governing the possession and use of
biological agents and toxins listed pursuant to subsection
(a)(1) in order to protect the public health and safety, in-
cluding the measures, safeguards, procedures, and avail-
ability of such agents and toxins described in paragraphs
(1) through (4) of subsection (b), respectively.
‘‘(d) REGISTRATION
AND TRACEABILITY MECHA-
NISMS; DATABASE.—Regulations under subsections (b)
and (c) shall require registration of the possession, use,
and transfer of biological agents and toxins listed pursu-
ant to subsection (a)(1), and such registration shall in-
clude (if available to the registered person) information
regarding the characterization of such biological agents
and toxins to facilitate their identification and traceability.
The Secretary shall maintain a national database of the
location of such agents and toxins, with information re-
garding their characterizations.
‘‘(e) INSPECTIONS.—The Secretary may conduct in-
spections to ensure that persons subject to regulations
under subsection (b) or (c) are in compliance with such
regulations, including provisions regarding security and
restrictions on access under subsection (g).
‘‘(f) EXEMPTIONS.—The Secretary may establish ex-
emptions from the applicability of provisions of regulations
under subsection (b) or (c) if the Secretary determines
that such exemptions are consistent with protecting the
public health and safety. In the case of a clinical labora-
tory that is in possession of a biological agent or toxin
listed pursuant to subsection (a)(1), such an exemption
may be provided only if such agent or toxin has been pre-
sented for diagnosis, verification, or proficiency testing,
and upon identification or verification of the agent or
toxin, such laboratory—
‘‘(1) promptly notifies the Secretary or other
public health authorities when required under Fed-
eral or State law; and
‘‘(2) transfers or destroys the agent or toxin in
accordance with such regulations.
‘‘(g) SECURITY REQUIREMENTS
FOR REGISTERED
PERSONS.—
‘‘(1) IN GENERAL.—In carrying out the provi-
sions of subsections (b) and (c) that relate to safe-
guards, the Secretary, in consultation with the At-
torney General, shall by regulation establish appro-
priate security requirements for persons possessing,
using, or transferring biological agents or toxins list-
ed pursuant to subsection (a)(1), and ensure compli-
ance with such requirements as a condition of reg-
istration under subsection (b) or (c).
‘‘(2) LIMITING ACCESS TO LISTED AGENTS AND
TOXINS.—
‘‘(A) IN
GENERAL.—Regulations issued
under subsections (b) and (c) shall include
provisions—
‘‘(i) to restrict access to biological
agents and toxins listed pursuant to sub-
section (a)(1) to only those individuals who
have a legitimate need for access, as deter-
mined according to the purposes for which
the registration under such regulations is
provided; and
‘‘(ii) to ensure that individuals grant-
ed such access are not—
‘‘(I) restricted persons, as de-
fined in section 175b of title 18,
United States Code;
‘‘(II) named in a warrant issued
to a Federal or State law enforcement
agency for participation in any domes-
tic or international act of terrorism or
other act of violence;
‘‘(III) under investigation for in-
volvement with a domestic or inter-
national terrorist or criminal organi-
zation by any Federal law enforce-
ment or intelligence agency; or
‘‘(IV) suspected by any Federal
law enforcement or intelligence agency
of seeking to obtain covertly informa-
tion relating to biological agents or
toxins on behalf of the intelligence or
military operations of a foreign na-
tion.
‘‘(B) SCREENING
PROTOCOL.—To carry
out subparagraph (A), the Secretary shall re-
quire that registered persons promptly submit
the names and other identifying information for
individuals described in subparagraph (A)(i) to
the Secretary and the Attorney General, with
which information the Attorney General shall
promptly use criminal, immigration, and na-
tional security databases available to the Fed-
eral Government to identify whether such indi-
viduals satisfy the conditions for access under
subparagraph (A)(ii). The Secretary, in con-
sultation with the Attorney General and other
Federal agencies, shall periodically review and
as appropriate revise the protocol for screening
individuals for purposes of subparagraph (A),
and may require by regulation additional
screening measures if determined necessary to
achieve the purposes of this section.
‘‘(3) ASSISTANCE
FOR
CERTAIN
ENTITIES.—
The Secretary, in consultation with the Attorney
General, may make awards of grants, contracts, or
cooperative agreements to public and nonprofit pri-
vate entities (other than Federal agencies), and may
provide technical assistance to such entities, to im-
prove security of the facilities of registered persons.
‘‘(h) DISCLOSURE OF INFORMATION.—
‘‘(1) IN
GENERAL.—Any information in the
possession of any Federal agency that identifies a
person, or the geographic location of a person, who
is registered pursuant to regulations under this sec-
tion (including regulations promulgated before the
effective date of this subsection), and any site-spe-
cific information relating to the type, quantity, or
identity of a biological agent or toxin listed pursuant
to subsection (a)(1) or the site-specific security
mechanisms in place to protect such agents and tox-
ins, shall not be disclosed under section 552(a) of
title 5, United States Code.
‘‘(2) DISCLOSURES FOR PUBLIC HEALTH AND
SAFETY; CONGRESS.—Nothing in this section may be
construed as preventing the head of any Federal
agency—
‘‘(A) from making disclosures of informa-
tion described in paragraph (1) for purposes of
protecting the public health and safety; or
‘‘(B) from making disclosures of such in-
formation to any committee or subcommittee of
the Congress with appropriate jurisdiction,
upon request.
‘‘(i) CIVIL MONEY PENALTY.—
‘‘(1) IN GENERAL.—In addition to any other
penalties that may apply under law, any person who
violates any provision of regulations under sub-
section (b) or (c) shall be subject to the United
States for a civil money penalty in an amount not
exceeding $250,000 in the case of an individual and
$500,000 in the case of any other person.
‘‘(2) 
APPLICABILITY
OF
CERTAIN
PROVI-
SIONS.—The provisions of section 1128A of the So-
cial Security Act (other than subsections (a), (b),
(h), and (i), the first sentence of subsection (c), and
paragraphs (1) and (2) of subsection (f)) shall apply
to a civil money penalty under paragraph (1) in the
same manner as such provisions apply to a penalty
or proceeding under section 1128A(a) of such Act.
The Secretary may delegate authority under this
subsection in the same manner as provided in sec-
tion 1128A(j)(2) of the Social Security Act, and
such authority shall include all powers as contained
in section 6 of the Inspector General Act of 1978.
‘‘(j) COORDINATION WITH REGULATIONS UNDER
VIRUS-SERUM-TOXIN ACT.—
‘‘(1) IN GENERAL.—In establishing and enforc-
ing regulations under subsections (b) and (c), the
Secretary shall consult with the Secretary of Agri-
culture to ensure that such activities are coordi-
nated, to the greatest extent practicable, with regu-
lations governing certain biological agents and toxins
listed pursuant to subsection (a)(1) issued by the
Secretary of Agriculture under the Act commonly
known as the Virus-Serum-Toxin Act (the eighth
paragraph under the heading ‘Bureau of Animal In-
dustry’ in the Act of March 4, 1913; 21 U.S.C. 151-
159) (in this subsection referred to as the ‘VST
Act’). The purpose of such coordination shall be—
‘‘(A) to minimize any conflicts between the
regulations issued by, or the activities of, the
Secretary of Health and Human Services and
the Secretary of Agriculture with respect to
such agents and toxins;
‘‘(B) to minimize the administrative bur-
den on persons subject to regulations under
both this section and the VST Act;
‘‘(C) to ensure the appropriate availability
of such agents and toxins for legitimate agricul-
tural or veterinary research, education, or other
such purposes; and
‘‘(D) to ensure the establishment of a na-
tional database of such agents or toxins pursu-
ant to subsection (d).
‘‘(2) PERSONS
REGULATED
BY
DEPARTMENT
OF
AGRICULTURE.—With respect to persons pos-
sessing or using biological agents or toxins listed
pursuant to subsection (a)(1) who, as of the date of
enactment of the Public Health Security and Bioter-
rorism Response Act of 2001, possess an unexpired,
unrevoked, and unsuspended permit or license from
the Department of Agriculture for such possession
or use, such persons may, for purposes of registra-
tion under subsection (b) or (c), submit to the Sec-
retary of Health and Human Services the same in-
formation previously provided to the Secretary of
Agriculture to obtain such permit or license, pro-
vided that the information so submitted is accurate
as of the time of submittal to the Secretary of
Health and Human Services, and provided further
that such Secretary may, after review of such sub-
mission, request such additional information as the
Secretary determines to be necessary to achieve the
purposes of this section.
‘‘(3) SAVINGS PROVISION.—Nothing in this sec-
tion shall be construed as limiting any authority of
the Secretary of Agriculture under the VST Act or
any regulations issued thereunder.
‘‘(k) DEFINITIONS.—For purposes of this section:
‘‘(1) The terms ‘biological agent’ and ‘toxin’
have the meanings given such terms in section 178
of title 18, United States Code.
‘‘(2) The term ‘registered person’ means a per-
son registered under regulations under subsection
(b) or (c).
‘‘(l) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated such sums as may be necessary for
each of the fiscal years 2002 through 2006.’’.
(2) RELATION TO OTHER LAWS.—
(A) RULE
OF
CONSTRUCTION.—Regula-
tions promulgated by the Secretary of Health
and Human Services under section 511 of the
Antiterrorism and Effective Death Penalty Act
of 1996 are deemed to have been promulgated
under section 351A of the Public Health Serv-
ice Act, as added by paragraph (1) of this sub-
section. Such regulations, including the list
under subsection (d)(1) of such section 511,
that were in effect on the day before the date
of the enactment of this Act remain in effect
until modified by the Secretary (including any
revisions required under subsection (a)(2) of
such section 351A).
(B) 
CONFORMING
AMENDMENT.—Sub-
sections (d), (e), (f), and (g) of section 511 of
the Antiterrorism and Effective Death Penalty
Act of 1996 (42 U.S.C. 262 note) are repealed.
(3) DATE
CERTAIN
FOR
PROMULGATION
OF
CERTAIN REGULATIONS; EFFECTIVE DATE REGARD-
ING CRIMINAL AND CIVIL PENALTIES.—With respect
to section 351A of the Public Health Service Act (as
added by paragraph (1) of this subsection):
(A) Not later than 30 days after the date
of the enactment of this Act, the Secretary of
Health and Human Services shall promulgate
an interim final rule requiring all persons in
possession of biological agents or toxins listed
pursuant to subsection (a)(1) of such section
(unless exempt under subsection (e) of such
section) to provide notice to the Secretary of
such possession, and to include in the notice
such additional information as the Secretary
may require for compliance with subsection (d)
of such section or any other provision of such
section, by not later than 30 days after the date
on which such rule is promulgated. Such in-
terim final rule takes effect on the date on
which the rule is promulgated, except as fol-
lows:
(i) For purposes of section 175b(c) of
title 18, United States Code (relating to
criminal penalties), as added by subsection
(a)(1)(E) of this section, the rule takes ef-
fect 60 days after the date on which the
rule is promulgated.
(ii) For purposes of subsection (i) of
such section 351A (relating to civil pen-
alties), the rule takes effect 60 days after
the date on which the rule is promulgated.
(B) Not later than 120 days after the date
of enactment of this Act, such Secretary shall
promulgate an interim final rule for carrying
out subsections (b) and (c) of such section
351A. Such interim final rule takes effect 60
days after the date on which the rule is promul-
gated.
(4) EFFECTIVE DATE REGARDING DISCLOSURE
OF INFORMATION.—Subsection (h) of section 351A
of the Public Health Service Act, as added by para-
graph (1) of this subsection, is deemed to have
taken 
effect 
on 
the 
effective 
date 
of 
the
Antiterrorism and Effective Death Penalty Act of
1996.
(b) CRIMINAL
PENALTIES
REGARDING
SELECT
AGENTS.—
(1) IN
GENERAL.—Section 175b of title 18,
United States Code, as added by section 817 of Pub-
lic Law 107–56, is amended—
(A) by striking ‘‘(a)’’ and inserting
‘‘(a)(1)’’;
(B) by transferring subsection (c) from the
current placement of the subsection and insert-
ing the subsection before subsection (b);
(C) by striking ‘‘(c)’’ and inserting ‘‘(2);
(D) by redesignating subsection (b) as sub-
section (d); and
(E) by inserting before subsection (d) (as
so redesignated) the following subsections:
‘‘(b) TRANSFER TO UNREGISTERED PERSON.—Who-
ever knowingly transfers a select agent to a person without
first verifying with the Secretary of Health and Human
Services that the person has obtained a registration re-
quired by regulations under subsection (b) or (c) of section
351A of the Public Health Service Act shall be fined under
this title, or imprisoned for not more than 5 years, or both.
‘‘(c) UNREGISTERED
FOR POSSESSION.—Whoever
knowingly possesses a biological agent or toxin where such
agent or toxin is a select agent for which such person has
not obtained a registration required by regulations under
section 351A(c) of the Public Health Service Act shall be
fined under this title, or imprisoned for not more than
5 years, or both.’’.
(2) CONFORMING AMENDMENTS.—Chapter 10
of title 18, United States Code, is amended—
(A) in section 175b (as added by section
817 of Public Law 107–56 and amended by
paragraph (1) of this subsection)—
(i) in subsection (d)(1), by striking
‘‘The term’’ and all that follows through
‘‘does not include’’ and inserting the fol-
lowing: ‘‘The term ‘select agent’ means a
biological agent or toxin to which sub-
section (a) applies. Such term (including
for purposes of subsection (a)) does not in-
clude’’; and
(ii) in the heading for the section, by
striking ‘‘Possession by restricted
persons’’ 
and 
inserting 
‘‘Select
agents’’; and
(B) in the chapter analysis, in the item re-
lating to section 175b, by striking ‘‘Possession
by restricted persons.’’ and inserting ‘‘Select
agents.’’.
(3) TECHNICAL CORRECTIONS.—Chapter 10 of
title 18, United States Code, as amended by section
817 of Public Law 107–56 and paragraphs (1) and
(2) of this subsection, is amended—
(A) in section 175—
(i) in subsection (a), in the second
sentence, by striking ‘‘this section’’ and in-
serting ‘‘this subsection’’; and
(ii) in subsection (c), by striking ‘‘pro-
tective’’ and all that follows and inserting
‘‘protective, bona fide research, or other
peaceful purposes.’’;
(B) in section 175b—
(i) in subsection (a)(1), by striking
‘‘described in subsection (b)’’ and all that
follows and inserting the following: ‘‘shall
ship or transport in or affecting interstate
or foreign commerce, or possess in or af-
fecting interstate or foreign commerce, any
biological agent or toxin, or receive any bi-
ological agent or toxin that has been
shipped or transported in interstate or for-
eign commerce, if the biological agent or
toxin is listed as a select agent in Appen-
dix A of part 72 of title 42, Code of Fed-
eral Regulations, pursuant to section 351A
of the Public Health Service Act, and is
not exempted under subsection (h) of sec-
tion 72.6, or Appendix A of part 72, of
title 42, Code of Federal Regulations.’’;
and
(ii) in subsection (d)(3), by striking
‘‘section 1010(a)(3)’’ and inserting ‘‘sec-
tion 101(a)(3)’’;
(C) in section 176(a)(1)(A), by striking
‘‘exists by reason of’’ and inserting ‘‘pertains
to’’; and
(D) in section 178—
(i) in paragraph (1), by striking
‘‘means any micro-organism’’ and all that
follows through ‘‘product, capable of’’ and
inserting the following: ‘‘means any micro-
organism (including, but not limited to,
bacteria, viruses, fungi, rickettsiae or pro-
tozoa), or infectious substance, or any nat-
urally occurring, bioengineered or syn-
thesized component of any such microorga-
nism or infectious substance, capable of’’;
(ii) in paragraph (2), by striking
‘‘means the toxic’’ and all that follows
through ‘‘including—’’ and inserting the
following: ‘‘means the toxic material or
product of plants, animals, microorganisms
(including, but not limited to, bacteria, vi-
ruses, fungi, rickettsiae or protozoa), or in-
fectious substances, or a recombinant or
synthesized molecule, whatever their origin
and method of production, and includes—
’’; and
(iii) in paragraph (4), by striking ‘‘re-
combinant molecule,’’ and all that follows
through ‘‘biotechnology,’’ and inserting
‘‘recombinant or synthesized molecule,’’.
(4) ADDITIONAL
TECHNICAL
CORRECTION.—
Section 2332a of title 18, United States Code, is
amended—
(A) in subsection (a), in the matter pre-
ceding paragraph (1), by striking ‘‘section
229F)’’ and all that follows through ‘‘section
178)—’’ and inserting ‘‘section 229F)—’’; and
(B) in subsection (c)(2)(C), by striking ‘‘a
disease organism’’ and inserting ‘‘a biological
agent, toxin, or vector (as those terms are de-
fined in section 178 of this title)’’.
(c) SECURITY UPGRADES AT THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES.—For the purpose of en-
abling the Secretary of Health and Human Services to se-
cure existing facilities of the Department of Health and
Human Services where biological agents or toxins listed
under section 351A(a)(1) of the Public Health Service Act
are housed or researched, or where vaccines are housed
or researched, there are authorized to be appropriated
such sums as may be necessary for fiscal year 2002 and
each subsequent fiscal year.
(d) REPORT TO CONGRESS.—Not later than 1 year
after the date of the enactment of this Act, the Secretary
of Health and Human Services, after consultation with
other appropriate Federal agencies, shall submit to the
Congress a report that—
(1) describes the extent to which there has been
compliance by governmental and private entities
with applicable regulations under section 351A of
the Public Health Service Act (as added by sub-
section (a) of this section), including the extent of
compliance before the date of the enactment of this
Act, and including the extent of compliance with
regulations promulgated after such date of enact-
ment;
(2) describes the actions to date and future
plans of the Secretary for updating the list of bio-
logical agents and toxins under such section 351A;
(3) describes the actions to date and future
plans of the Secretary for determining compliance
with regulations under such section 351A and for
taking appropriate enforcement actions; and
(4) provides any recommendations of the Sec-
retary for administrative or legislative initiatives re-
garding such section 351A.
TITLE III-AMENDMENTS TO FED-
ERAL FOOD, DRUG, AND COS-
METIC ACT
Subtitle A—Protection of Food
Supply
SEC. 301. PROTECTION AGAINST INTENTIONAL ADULTERA-
TION OF FOOD.
(a) INCREASING INSPECTIONS FOR DETECTION OF
INTENTIONAL ADULTERATION OF FOOD.—Section 801 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381) is amended by adding at the end the following sub-
section:
‘‘(h)(1) The Secretary shall give high priority to in-
creasing the number of inspections under this section for
the purpose of enabling the Secretary to inspect food of-
fered for import at ports of entry into the United States,
with the greatest priority given to inspections to detect
the intentional adulteration of food.’’.
(b) IMPROVEMENTS TO INFORMATION MANAGEMENT
SYSTEMS.—Section 801(h) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a) of this sec-
tion, is amended by adding at the end the following para-
graphs:
‘‘(2) The Secretary shall give high priority to making
necessary improvements to the information management
systems of the Food and Drug Administration that con-
tain information related to foods imported or offered for
import into the United States for purposes of improving
the ability of the Secretary to allocate resources, detect
the intentional adulteration of food, and facilitate the im-
portation of food that is in compliance with this Act.
‘‘(3) The Secretary shall submit to the Committee on
Energy and Commerce of the House of Representatives,
and the Committee on Health, Education, Labor, and
Pensions of the Senate, periodic reports describing the ac-
tivities of the Secretary under paragraphs (1) and (2).’’.
(c) TESTING
FOR RAPID DETECTION
OF INTEN-
TIONAL ADULTERATION OF FOOD.—Section 801 of the
Federal Food, Drug, and Cosmetic Act, as amended by
subsection (a) of this section, is amended by adding at
the end the following:
‘‘(i)(1) For use in inspections of food under this sec-
tion, the Secretary shall provide for research on the devel-
opment of tests and sampling methodologies—
‘‘(A) whose purpose is to test food in order
to rapidly detect the adulteration of the food,
with the greatest priority given to detect the in-
tentional adulteration of food; and
‘‘(B) whose results offer significant im-
provements over the available technology in
terms of accuracy, timing, or costs.
‘‘(2) In providing for research under paragraph (1),
the Secretary shall give priority to conducting research on
the development of tests that are suitable for inspections
of food at ports of entry into the United States.
‘‘(3) In providing for research under paragraph (1),
the Secretary shall as appropriate coordinate with the Di-
rector of the Centers for Disease Control and Prevention,
the Director of the National Institutes of Health, the Ad-
ministrator of the Environmental Protection Agency, and
the Secretary of Agriculture.
‘‘(4) The Secretary shall annually submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate, a report describing
the progress made in research under paragraph (1), in-
cluding progress regarding paragraph (2).’’.
(d) ASSESSMENT
OF THREAT
OF INTENTIONAL
ADULTERATION OF FOOD.—The Secretary of Health and
Human Services, acting through the Commissioner of
Food and Drugs, shall ensure that, not later than six
months after the date of the enactment of this Act—
(1) the assessment that (as of such date of en-
actment) is being conducted on the threat of the in-
tentional adulteration of food is completed; and
(2) a report describing the findings of the as-
sessment is submitted to the Committee on Energy
and Commerce of the House of Representatives and
to the Committee on Health, Education, Labor, and
Pensions of the Senate.
(e) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section and the amendments
made by this section, there are authorized to be appro-
priated $100,000,000 for fiscal year 2002, and such sums
as may be necessary for each of the fiscal years 2003
through 2006, in addition to other authorizations of ap-
propriations that are available for such purpose.
SEC. 302. ADMINISTRATIVE DETENTION.
(a) EXPANDED AUTHORITY.—Section 304 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334)
is amended by adding at the end the following subsection:
‘‘(h) ADMINISTRATIVE DETENTION OF FOODS.—
‘‘(1) DETENTION AUTHORITY.—
‘‘(A) IN GENERAL.—An officer or qualified
employee of the Food and Drug Administration
may order the detention, in accordance with
this subsection, of any article of food that is
found during an inspection, examination, or in-
vestigation under this Act conducted by such
officer or qualified employee, if the officer or
qualified employee has credible evidence or in-
formation indicating that such article presents
a threat of serious adverse health consequences
or death to humans or animals.
‘‘(B) SECRETARY’S APPROVAL.—An article
of food may be ordered detained under subpara-
graph (A) only if the Secretary or an official
designated by the Secretary approves the order.
An official may not be so designated unless the
official is the director of the district under this
Act in which the article involved is located, or
is an official senior to such director.
‘‘(2) PERIOD
OF
DETENTION.—An article of
food may be detained under paragraph (1) for a rea-
sonable period, not to exceed 20 days, unless a
greater period, not to exceed 30 days, is necessary,
to enable the Secretary to institute an action under
subsection (a) or section 302. The Secretary shall by
regulation provide for procedures for instituting such
action on an expedited basis with respect to perish-
able foods.
‘‘(3) SECURITY
OF
DETAINED
ARTICLE.—An
order under paragraph (1) with respect to an article
of food may require that such article be labeled or
marked as detained, and may require that the article
be removed to a secure facility. An article subject to
such an order shall not be transferred by any person
from the place at which the article is ordered de-
tained, or from the place to which the article is so
removed, as the case may be, until released by the
Secretary or until the expiration of the detention pe-
riod applicable under such order, whichever occurs
first.
‘‘(4) APPEAL OF DETENTION ORDER.—With re-
spect to an article of food ordered detained under
paragraph (1), any person who would be entitled to
be a claimant for such article if the article were
seized under subsection (a) may appeal the order to
the Secretary. Within 72 hours after such an appeal
is filed, the Secretary, after providing opportunity
for an informal hearing, shall confirm or terminate
the order involved, and such confirmation by the
Secretary shall be considered a final agency action
100
for purposes of section 702 of title 5, United States
Code. If during such 72-hour period the Secretary
fails to provide such an opportunity, or to confirm
or terminate such order, the order is deemed to be
terminated.’’.
(b) PROHIBITED ACT.—Section 301 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following:
‘‘(bb) The transfer of an article of food in violation
of an order under section 304(h), or the removal or alter-
ation of any mark or label required by the order to identify
the article as detained.’’.
(c) TEMPORARY HOLDS AT PORTS OF ENTRY.—Sec-
tion 801 of the Federal Food, Drug, and Cosmetic Act,
as amended by section 301(c) of this Act, is amended by
adding at the end the following:
‘‘(j)(1) If an officer or qualified employee of the Food
and Drug Administration has credible evidence or infor-
mation indicating that an article of food presents a threat
of serious adverse health consequences or death to humans
or animals, and such officer or qualified employee is un-
able to inspect, examine, or investigate such article upon
the article being offered for import at a port of entry into
the United States, the officer or qualified employee shall
request the Secretary of Treasury to hold the food at the
101
port of entry for a reasonable period of time, not to exceed
24 hours, for the purpose of enabling the Secretary to in-
spect, examine, or investigate the article as appropriate.
‘‘(2) The Secretary shall request the Secretary of
Treasury to remove an article held pursuant to paragraph
(1) to a secure facility, as appropriate. During the period
of time that such article is so held, the article shall not
be transferred by any person from the port of entry into
the United States for the article, or from the secure facil-
ity to which the article has been removed, as the case may
be.
‘‘(3) An officer or qualified employee of the Food and
Drug Administration may make a request under para-
graph (1) only if the Secretary or an official designated
by the Secretary approves the request. An official may not
be so designated unless the official is the director of the
district under this Act in which the article involved is lo-
cated, or is an official senior to such director.
‘‘(4) With respect to an article of food for which a
request under paragraph (1) is made, the Secretary,
promptly after the request is made, shall notify the State
in which the port of entry involved is located that the re-
quest has been made, and as applicable, that such article
is being held under this subsection.’’.
102
SEC. 303. PERMISSIVE DEBARMENT REGARDING FOOD IM-
PORTATION.
(a) IN GENERAL.—Section 306(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is
amended—
(1) in paragraph (1)—
(A) in subparagraph (A), by striking ‘‘or’’
after the comma at the end;
(B) in subparagraph (B), by striking the
period at the end and inserting ‘‘, or’’; and
(C) by adding at the end the following sub-
paragraph:
‘‘(C) a person from importing an article of
food or offering such an article for import into
the United States.’’;
(2) in paragraph (2), in the matter preceding
subparagraph (A), by inserting ‘‘subparagraph (A)
or (B) of’’ before ‘‘paragraph (1)’’;
(3) by redesignating paragraph (3) as para-
graph (4); and
(4) by inserting after paragraph (2) the fol-
lowing paragraph:
‘‘(3) PERSONS
SUBJECT
TO
PERMISSIVE
DE-
BARMENT; FOOD IMPORTATION.—A person is subject
to debarment under paragraph (1)(C) if—
103
‘‘(A) the person has been convicted of a
felony for conduct relating to the importation
into the United States of any article of food; or
‘‘(B)(i) the person has repeatedly imported
or offered for import adulterated articles of
food; and
‘‘(ii) the person knew, or should have
known, that such articles were adulterated.’’.
(b) CONFORMING AMENDMENTS.—Section 306 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a)
is amended—
(1) in subsection (a), in the heading for the
subsection, 
by 
striking 
‘‘MANDATORY
DEBAR-
MENT.—’’ and inserting ‘‘MANDATORY DEBARMENT;
CERTAIN DRUG APPLICATIONS.—’’;
(2) in subsection (b)—
(A) in the heading for the subsection, by
striking ‘‘PERMISSIVE DEBARMENT.—’’ and in-
serting ‘‘PERMISSIVE DEBARMENT; CERTAIN
DRUG APPLICATIONS; FOOD IMPORTS.—’’; and
(B) in paragraph (2), in the heading for
the paragraph, by striking ‘‘PERMISSIVE
DE-
BARMENT.—’’ and inserting ‘‘PERMISSIVE DE-
BARMENT; CERTAIN DRUG APPLICATIONS.—’’;
104
(3) in subsection (c)(2)(A)(iii), by striking
‘‘subsection (b)(2)’’ and inserting ‘‘paragraph (2) or
(3) of subsection (b)’’;
(4) in subsection (d)(3)—
(A) in subparagraph (A)(i), by striking ‘‘or
(b)(2)(A)’’ and inserting ‘‘ or paragraph (2)(A)
or (3) of subsection (b)’’;
(B) in subparagraph (A)(ii)(II), by insert-
ing ‘‘in applicable cases,’’ before ‘‘sufficient au-
dits’’; and
(C) in subparagraph (B), in each of
clauses (i) and (ii), by inserting ‘‘or subsection
(b)(3)’’ after ‘‘subsection (b)(2)(B).
(c) EFFECTIVE DATES.—Section 306(l)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
335a(l)(2)) is amended—
(1) in the first sentence—
(A) by striking ‘‘and’’ after ‘‘subsection
(b)(2)’’; and
(B) by inserting ‘‘, and subsection (b)(3)’’
after ‘‘subsection (b)(2)(B)’’; and
(2) in the second sentence, by inserting ‘‘, sub-
section (b)(3),’’ after ‘‘subsection (b)(2)(B)’’.
(d) PROHIBITED ACT.—Section 301 of the Federal
Food, Drug, and Cosmetic Act, as amended by section
105
302(b) of this Act, is amended by adding at the end the
following:
‘‘(cc) The importing or offering for import into the
United States of an article of food by, with the assistance
of, or at the direction of, a person debarred under section
306(b)(1)(C).’’.
SEC. 304. MAINTENANCE AND INSPECTION OF RECORDS
FOR FOODS.
(a) IN GENERAL.—Chapter IV of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend-
ed by adding at the end the following section:
‘‘SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.
‘‘(a) RECORDS INSPECTION.—If the Secretary has
credible evidence or information indicating that an article
of food presents a threat of serious adverse health con-
sequences or death to humans or animals, each person (ex-
cluding farms and restaurants) who manufactures, proc-
esses, packs, distributes, receives, holds, or imports such
article shall, at the request of an officer or employee duly
designated by the Secretary, permit such officer or em-
ployee, upon presentation of appropriate credentials and
a written notice to such person, at reasonable times and
within reasonable limits and in a reasonable manner, to
have access to and copy all records relating to such article
that are needed to assist the Secretary in investigating
106
such credible evidence or information. The requirement
under the preceding sentence applies to all records relating
to the manufacture, processing, packing, distribution, re-
ceipt, holding, or importation of such article maintained
by or on behalf of such person in any format (including
paper and electronic formats) and at any location.
‘‘(b) 
REGULATIONS
CONCERNING
RECORD-
KEEPING.—The Secretary, in consultation and coordina-
tion, as appropriate, with other Federal departments and
agencies with responsibilities for regulating food safety,
may by regulation establish requirements regarding the
maintenance of records by persons (excluding farms and
restaurants) who manufacture, process, pack, transport,
distribute, receive, hold, or import food, as may be nec-
essary to trace the source and chain of distribution of food
and its packaging in order to address credible threats of
serious adverse health consequences or death to humans
or animals. The Secretary shall take into account the size
of a business in promulgating regulations under this sec-
tion.
‘‘(c) PROTECTION OF SENSITIVE INFORMATION.—
The Secretary shall take appropriate measures to ensure
that there are in effect effective procedures to prevent the
unauthorized disclosure of any trade secret or confidential
107
information that is obtained by the Secretary pursuant to
this section.
‘‘(d) LIMITATIONS.—This section shall not be
construed—
‘‘(1) to limit the authority of the Secretary to
inspect records or to require maintenance of records
under any other provision of this Act;
‘‘(2) to authorize the Secretary to impose any
requirements with respect to a food to the extent
that it is within the exclusive jurisdiction of the Sec-
retary of Agriculture pursuant to the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), or
the Egg Products Inspection Act (21 U.S.C. 1031 et
seq);
‘‘(3) to have any legal effect on section 552 of
title 5, United States Code, or section 1905 of title
18, United States Code; or
‘‘(4) to extend to recipes for food, financial
data, pricing data, personnel data, research data, or
sales data (other than shipment data regarding
sales).’’.
(b) FACTORY INSPECTION.—Section 704(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a))
is amended—
108
(1) in paragraph (1), by inserting after the first
sentence the following new sentence: ‘‘In the case of
any person (excluding farms and restaurants) who
manufactures, processes, packs, transports, distrib-
utes, holds, or imports foods, the inspection shall ex-
tend to all records and other information described
in section 414 when the Secretary has credible evi-
dence or information indicating that an article of
food presents a threat of serious adverse health con-
sequences or death to humans or animals, subject to
the limitations established in section 414(d).’’; and
(2) in paragraph (2), in the matter preceding
subparagraph (A), by striking ‘‘second sentence’’
and inserting ‘‘third sentence’’.
(c) PROHIBITED ACT.—Section 301(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) is
amended—
(1) by striking ‘‘by section 412, 504, or 703’’
and inserting ‘‘by section 412, 414, 504, 703, or
704(a); and
(2) by striking ‘‘under section 412’’ and insert-
ing ‘‘under section 412, 414(b)’’.
SEC. 305. REGISTRATION.
(a) IN GENERAL.—Chapter IV of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.), as
109
amended by section 304 of this Act, is amended by adding
at the end the following:
‘‘SEC. 415. REGISTRATION.
‘‘(a) REGISTRATION.—
‘‘(1) IN
GENERAL.—Any facility (excluding
farms) engaged in manufacturing, processing, pack-
ing, or holding food for consumption in the United
States shall be registered with the Secretary. To be
registered—
‘‘(A) for a domestic facility, the owner, op-
erator, or agent in charge of the facility shall
submit a registration to the Secretary; and
‘‘(B) for a foreign facility, the owner, oper-
ator, or agent in charge of the facility shall sub-
mit a registration to the Secretary and shall in-
clude with the registration the name of the
United States agent for the facility.
‘‘(2) REGISTRATION.—An entity (referred to in
this section as the ‘registrant’) shall submit a reg-
istration under paragraph (1) to the Secretary con-
taining information necessary to notify the Secretary
of the identity and address of each facility at which,
and all trade names under which, the registrant con-
ducts business and, when determined necessary by
the Secretary through guidance, the general food
110
category (as identified under section 170.3 of title
21, Code of Federal Regulations, or successor regu-
lations) of any food manufactured, processed,
packed, or held at such facility. The registrant shall
notify the Secretary in a timely manner of changes
to such information.
‘‘(3) PROCEDURE.—Upon receipt of a com-
pleted registration described in paragraph (1), the
Secretary shall notify the registrant of the receipt of
such registration and assign a registration number
to each registered facility.
‘‘(4) LIST.—The Secretary shall compile and
maintain an up-to-date list of facilities that are reg-
istered under this section. Such list and other infor-
mation required to be submitted under this sub-
section shall not be subject to the disclosure require-
ments of section 552 of title 5, United States Code.
‘‘(b) EXEMPTION.—The Secretary shall by regulation
exempt types of retail establishments from the require-
ments of subsection (a) only if the Secretary determines
that the registration of such facilities is not needed for
effective enforcement of this chapter and any regulations
issued under this chapter.
‘‘(c) FACILITY.—For purposes of this section, the
term ‘facility’ includes any factory, warehouse, or estab-
111
lishment (including a factory, warehouse, or establishment
of an importer), that manufactures, processes, packs, or
holds food. Such term does not include restaurants or
other establishments in which food is served solely for im-
mediate human consumption.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to authorize the Secretary to re-
quire an application, review, or licensing process.’’.
(b) PROHIBITED ACTS.—
(1) IN GENERAL.—Section 301 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331), as
amended by section 303(d) of this Act, is amended
by adding at the end the following:
‘‘(dd) The failure to register in accordance with sec-
tion 415.’’.
(2) MISBRANDED FOOD.—Section 403 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
343) is amended by adding at the end the following:
‘‘(t) If it is manufactured, processed, packed, or held
in a facility that is not registered in accordance with sec-
tion 415.’’.
(c) EFFECTIVE DATE.—The amendment made by
subsection (b) shall take effect 180 days after the date
of the enactment of this Act.
112
(d) NOTICE.—Not later than 60 days after the date
of the enactment of this Act, the Secretary of Health and
Human Services, after consultation with appropriate State
and local officials, shall take sufficient measures to notify
entities that manufacture, process, pack, or hold food for
consumption in the United States of the requirement pur-
suant to this section that facilities be registered with the
Secretary. The Secretary shall develop guidance, as need-
ed, to identify facilities required to register under this sec-
tion.
(e) ELECTRONIC FILING.—For the purpose of reduc-
ing paperwork and reporting burdens, the Secretary of
Health and Human Services may provide for, and encour-
age the use of, electronic methods of submitting to the
Secretary registrations required pursuant to this section.
In providing for the electronic submission of such registra-
tions, the Secretary shall ensure adequate authentication
protocols are used to enable identification of the registrant
and validation of the data as appropriate.
(f) SAVINGS CLAUSE.—This section may not be con-
strued as authorizing the Secretary of Health and Human
Services to impose any requirements with respect to a food
to the extent that it is within the exclusive jurisdiction
of the Secretary of Agriculture pursuant to the Federal
Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
113
Products Inspection Act (21 U.S.C. 451 et seq.), or the
Egg Products Inspection Act (21 U.S.C. 1031 et seq).
SEC. 306. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.
(a) IN GENERAL.—Section 801 of the Federal Food,
Drug, and Cosmetic Act, as amended by section 302(c)
of this Act, is amended by adding at the end the following
subsection:
‘‘(k)(1) In the case of an article of food that is being
imported or offered for import into the United States, the
Secretary, after consultation with the Secretary of the
Treasury, shall by regulation require, for the purpose of
enabling such article to be inspected at ports of entry into
the United States, the submission to the Secretary of a
notice providing the identity of each of the following: The
article; the manufacturer and shipper of the article, and
if known within the specified period of time that notice
is required to be provided, the grower of the article; the
country from which the article originates; the country
from which the article is shipped; and the anticipated port
of entry for the article. An article of food imported or of-
fered for import without submission of such notice in ac-
cordance with regulations under this paragraph shall be
refused admission into the United States. Nothing in this
section may be construed as a limitation on the port of
entry for an article of food.
114
‘‘(2)(A) Regulations under paragraph (1) shall re-
quire that a notice under such paragraph be provided by
a specified period of time, not fewer than 24 hours, in
advance of the time of the importation of the article of
food involved or the offering of the food for import, except
that the advance period so required may not exceed 72
hours.
‘‘(B)(i) If an article of food is being imported or of-
fered for import into the United States and a notice under
paragraph (1) is not provided in advance in accordance
with subparagraph (A), such article shall be held at the
port of entry for the article, and may not be delivered to
the importer, owner, or consignee of the article, until such
notice is submitted to the Secretary, and the Secretary
examines the notice and determines that the notice is in
accordance with regulations under paragraph (1). The
preceding sentence may not be construed as authorizing
such delivery pursuant to the execution of a bond, pending
such a determination by the Secretary.
‘‘(ii) In carrying out clause (i) with respect to an arti-
cle of food, the Secretary shall determine whether there
is in the possession of the Secretary any credible evidence
or information indicating that such article presents a
threat of serious adverse health consequences or death to
humans or animals.
115
‘‘(3)(A) This subsection may not be construed as lim-
iting the authority of the Secretary to obtain information
under any other provision of this Act.
‘‘(B) This subsection may not be construed as au-
thorizing the Secretary to impose any requirements with
respect to a food to the extent that it is within the exclu-
sive jurisdiction of the Secretary of Agriculture pursuant
to the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.), the Poultry Products Inspection Act (21 U.S.C. 451
et seq.), or the Egg Products Inspection Act (21 U.S.C.
1031 et seq).’’.
(b) PROHIBITED ACT.—Section 301 of the Federal
Food, Drug, and Cosmetic Act, as amended by section
305(b)(1) of this Act, is amended by adding at the end
the following:
‘‘(ee) The importing or offering for import into the
United States of an article of food in violation of regula-
tions under section 801(k).’’.
SEC. 307. AUTHORITY TO MARK ARTICLES REFUSED ADMIS-
SION INTO UNITED STATES.
(a) IN GENERAL.—Section 801 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended
by section 306(a) of this Act, is amended by adding at
the end the following:
116
‘‘(l)(1) If a food has been refused admission under
subsection (a), other than such a food that is required to
be destroyed, and the Secretary determines that the food
presents a threat of serious adverse health consequences
or death to humans or animals, the Secretary may require
the owner or consignee of the food to affix to the container
of the food a label that clearly and conspicuously bears
the 
statement: 
‘UNITED 
STATES: 
REFUSED
ENTRY’.
‘‘(2) All expenses in connection with affixing a label
under paragraph (1) shall be paid by the owner or con-
signee of the food involved, and in default of such pay-
ment, shall constitute a lien against future importations
made by such owner or consignee.
‘‘(3) A requirement under paragraph (1) remains in
effect until the Secretary determines that the food involved
has been brought into compliance with this Act.’’.
(b) MISBRANDED FOODS.—Section 403 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 343), as
amended by section 305(b)(2) of this Act, is amended by
adding at the end the following:
‘‘(u) If it fails to bear a label required by the Sec-
retary under section 801(l)(1) (relating to food refused ad-
mission into the United States).’’.
117
(c) RULE OF CONSTRUCTION.—With respect to arti-
cles of food that are imported or offered for import into
the United States, nothing in this section shall be con-
strued to limit the authority of the Secretary of Health
and Human Services or the Secretary of the Treasury to
require the marking of refused articles of food under any
other provision of law.
SEC. 308. PROHIBITION AGAINST PORT SHOPPING FOR IM-
PORTATION.
Section 402 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 342) is amended by adding at the end the
following:
‘‘(h) If it is an article of food imported or offered
for import into the United States and such article has pre-
viously been refused admission under section 801(a), un-
less the person reoffering the article affirmatively estab-
lishes, at the expense of the owner or consignee of the
article, that the article is not adulterated, as determined
by the Secretary.’’.
SEC. 309. NOTICES TO STATES REGARDING IMPORTED
FOOD.
Chapter IX of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 391 et seq.) is amended by adding at the
end the following new section:
118
‘‘SEC. 908. NOTICES TO STATES REGARDING IMPORTED
FOOD.
‘‘(a) IN GENERAL.—If the Secretary has credible evi-
dence or information indicating that a shipment of im-
ported food or portion thereof presents a threat of serious
adverse health consequences or death to humans or ani-
mals, the Secretary shall provide notice regarding such
threat to the States in which the food is held or will be
held, and to the States in which the manufacturer, packer,
or distributor of the food is located, to the extent that
the Secretary has knowledge of which States are so in-
volved. In providing the notice to a State, the Secretary
shall request the State to take such action as the State
considers appropriate, if any, to protect the public health
regarding the food involved.
‘‘(b) RULE OF CONSTRUCTION.—Subsection (a) may
not be construed as limiting the authority of the Secretary
with respect to adulterated food under any other provision
of this Act.’’.
SEC. 310. GRANTS TO STATES FOR INSPECTIONS; RE-
SPONSE TO NOTICE REGARDING ADULTER-
ATED IMPORTED FOOD.
Chapter IX of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 391 et seq.), as amended by section 309
of this Act, is amended by adding at the end the following
new section:
119
‘‘SEC. 909. GRANTS TO STATES REGARDING FOOD INSPEC-
TIONS.
‘‘(a) IN GENERAL.—The Secretary may make grants
to States and Territories for the purpose of conducting
with respect to food examinations, inspections, investiga-
tions, and related activities under section 702 through in-
dividuals who, under subsection (a) of such section, are
duly commissioned by the Secretary as officers of the De-
partment.
‘‘(b) NOTICES
REGARDING
ADULTERATED
IM-
PORTED FOOD.—The Secretary may make grants to the
States for the purpose of assisting the States with the
costs of taking appropriate action to protect the public
health in response to notices under section 908, including
planning and otherwise preparing to take such action.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated such sums as may be necessary for
each of the fiscal years 2002 through 2006.’’.
Subtitle B—Protection of Drug
Supply
SEC. 311. ANNUAL REGISTRATION OF FOREIGN MANUFAC-
TURERS; 
SHIPPING 
INFORMATION; 
DRUG
AND DEVICE LISTING.
(a) ANNUAL REGISTRATION; LISTING.—
120
(1) IN GENERAL.—Section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360) is
amended—
(A) in subsection (i)(1)—
(i) by striking ‘‘Any establishment’’
and inserting ‘‘On or before December 31
of each year, any establishment’’;
(ii) by striking ‘‘establishment and the
name’’ and inserting ‘‘establishment, the
name’’; and
(iii) by inserting before the period the
following: ‘‘, the name of each importer of
such drug or device in the United States
that is known to the establishment, and
the name of each carrier used by the estab-
lishment in transporting such drug or de-
vice to the United States for purposes of
importation’’; and
(B) in subsection (j)(1), in the first sen-
tence, by striking ‘‘or (d)’’ and inserting ‘‘(d),
or (i)’’.
(2) MISBRANDING.—Section 502(o) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C.
352(o)) is amended by striking ‘‘in any State’’.
121
(b) IMPORTATION; STATEMENT REGARDING REG-
ISTRATION OF MANUFACTURER.—
(1) IN GENERAL.—Section 801 of the Federal
Food, Drug, and Cosmetic Act, as amended by sec-
tion 307(a) of this Act, is amended by adding at the
end the following subsection:
‘‘(m) A drug or device that is imported or offered
for import into the United States may be refused admis-
sion if the importer of the drug or device does not, at the
time of offering the drug or device for import, submit to
the Secretary a statement that identifies the registration
under section 510(i) of each establishment that with re-
spect to such drug or device is required under such section
to register with the Secretary.’’.
(2) PROHIBITED ACT.—Section 301 of the Fed-
eral Food, Drug, and Cosmetic Act, as amended by
section 306(b) of this Act, is amended by adding at
the end the following:
‘‘(ff) The importing or offering for import into the
United States of a drug or device with respect to which
there is a failure to comply with an order of the Secretary
to submit to the Secretary a statement under section
801(m).’’.
(c) EFFECTIVE DATE.—The amendments made by
this section take effect upon the expiration of the 180-
122
day period beginning on the date of the enactment of this
Act.
SEC. 312. REQUIREMENT OF ADDITIONAL INFORMATION
REGARDING 
IMPORT 
COMPONENTS 
IN-
TENDED FOR USE IN EXPORT PRODUCTS.
(a) IN GENERAL.—Section 801(d)(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)(3)) is
amended to read as follows:
‘‘(3)(A) Subject to subparagraph (B), no component
of a drug, no component part or accessory of a device,
or other article of device requiring further processing,
which is ready or suitable for use for health-related pur-
poses, and no article of a food additive, color additive, or
dietary supplement, including a product in bulk form,
shall be excluded from importation into the United States
under subsection (a) if each of the following conditions
is met:
‘‘(i) The importer of such article of a drug or
device or importer of such article of a food additive,
color additive, or dietary supplement submits to the
Secretary, at the time of initial importation, a state-
ment in accordance with the following:
‘‘(I) Such statement provides that such ar-
ticle is intended to be further processed by the
initial owner or consignee, or incorporated by
123
the initial owner or consignee, into a drug, bio-
logical product, device, food, food additive, color
additive, or dietary supplement that will be ex-
ported by the initial owner or consignee from
the United States in accordance with subsection
(e) or section 802, or with section 351(h) of the
Public Health Service Act.
‘‘(II) The statement identifies the manu-
facturer of such article and each processor,
packer, distributor, carrier, or other entity that
had possession of the article in the chain of
possession of the article from the manufacturer
to such importer of the article.
‘‘(ii) If such article is known to be, or to con-
tain or bear, any chemical substance or biological
substance, the statement under clause (i) is accom-
panied by such certificates of analysis as are nec-
essary to identify each such substance.
‘‘(iii) At the time of initial importation and be-
fore the delivery of such article to the importer or
the initial owner or consignee, such owner or con-
signee executes a good and sufficient bond providing
for the payment of such liquidated damages in the
event of default as may be required pursuant to reg-
ulations of the Secretary of the Treasury.
124
‘‘(iv) Such article is used and exported by the
initial owner or consignee in accordance with the in-
tent described under clause (i)(I), except for any
portions of the article that are destroyed.
‘‘(v) The initial owner or consignee maintains
records on the use or destruction of such article or
portions thereof, as the case may be, and submits to
the Secretary any such records requested by the Sec-
retary.
‘‘(vi) Upon request of the Secretary, the initial
owner or consignee submits a report that provides
an accounting of the exportation or destruction of
such article or portions thereof, and the manner in
which such owner or consignee complied with the re-
quirements of this subparagraph.
‘‘(B) Subparagraph (A) does not apply to the import
or offering for import into the United States of an article
if the Secretary determines that there is credible evidence
or information indicating that such article presents a
threat of serious adverse health consequences or death to
humans or animals.
‘‘(C) This section may not be construed as affecting
the responsibility of the Secretary to ensure that articles
imported into the United States under authority of sub-
125
paragraph (A) meet each of the conditions established in
such subparagraph for importation.’’.
(b) PROHIBITED ACT.—Section 301(w) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(w))
is amended to read as follows:
‘‘(w) The making of a knowingly false statement in
any statement, certificate of analysis, record, or report re-
quired or requested under section 801(d)(3); the failure
to submit a certificate of analysis as required under such
section; the failure to maintain records or to submit
records or reports as required by such section; the release
into interstate commerce of any article or portion thereof
imported into the United States under such section or any
finished product made from such article or portion, except
for export in accordance with section 801(e) or 802, or
with section 351(h) of the Public Health Service Act; or
the failure to so export or to destroy such an article or
portions thereof, or such a finished product.’’.
(c) EFFECTIVE DATE.—The amendments made by
this section take effect upon the expiration of the 90-day
period beginning on the date of the enactment of this Act.
126
TITLE IV-DRINKING WATER
SECURITY AND SAFETY
SEC. 401. AMENDMENT OF THE SAFE DRINKING WATER
ACT.
The Safe Drinking Water Act (title XIV of the Public
Health Service Act) is amended as follows:
(1) By inserting the following new sections
after section 1432:
‘‘SEC. 1433. TERRORIST AND OTHER INTENTIONAL ACTS.
‘‘(a) VULNERABILITY
ASSESSMENTS.—(1) Each
community water system serving a population of greater
than 3,300 persons shall conduct an assessment of the vul-
nerability of its system to a terrorist attack or other inten-
tional acts intended to substantially disrupt the ability of
the system to provide a safe and reliable supply of drink-
ing water. The vulnerability assessment shall include, but
not be limited to, a review of pipes and constructed con-
veyances, physical barriers, water collection, pretreatment,
treatment, storage and distribution facilities, electronic,
computer or other automated systems which are utilized
by the public water system, the use, storage, or handling
of various chemicals, and the operation and maintenance
of such system. The Administrator, not later than March
1, 2002, after consultation with appropriate departments
and agencies of the Federal Government and with State
127
and local governments, shall provide baseline information
to community water systems required to conduct vulner-
ability assessments regarding which kinds of terrorist at-
tacks or other intentional acts are the probable threats
to—
‘‘(A) substantially disrupt the ability of the sys-
tem to provide a safe and reliable supply of drinking
water; or
‘‘(B) otherwise present significant public health
concerns.
‘‘(2) Each community water system referred to in
paragraph (1) shall certify to the Administrator that the
system has conducted an assessment complying with para-
graph (1) prior to:
‘‘(A) December 31, 2002, in the case of systems
serving a population of 100,000 or more.
‘‘(B) June 30, 2003, in the case of systems
serving a population of 50,000 or more but less than
100,000.
‘‘(C) December 31, 2003, in the case of systems
serving a population greater than 3,300 but less
than 50,000.
‘‘(b) EMERGENCY RESPONSE PLAN.—Each commu-
nity water system serving a population greater than 3,300
shall prepare or revise, where necessary, an emergency re-
128
sponse plan that incorporates the results of vulnerability
assessments that have been completed. Each such commu-
nity water system shall certify to the Administrator, as
soon as reasonably possible after the enactment of this
section, but not later than 6 months after the completion
of the vulnerability assessment under subsection (a), that
the system has completed such plan. The emergency re-
sponse plan shall include, but not be limited to, plans, pro-
cedures, and identification of equipment that can be imple-
mented or utilized in the event of a terrorist or other in-
tentional attack on the public water system. The emer-
gency response plan shall also include actions, procedures,
and identification of equipment which can obviate or sig-
nificantly lessen the impact of terrorist attacks or other
intentional actions on the public health and the safety and
supply of drinking water provided to communities and in-
dividuals. Community water systems shall, to the extent
possible, coordinate with existing Local Emergency Plan-
ning Committees established under the Emergency Plan-
ning and Community Right-to-Know Act (42 U.S.C.
11001, et seq.) when preparing or revising an emergency
response plan under this subsection.
‘‘(c) GUIDANCE
TO SMALL PUBLIC WATER SYS-
TEMS.—The Administrator shall provide guidance to com-
munity water systems serving a population of less than
129
3,300 persons on how to conduct vulnerability assess-
ments, prepare emergency response plans, and address
threats from terrorist attacks or other intentional actions
designed to disrupt the provision of safe drinking water
or significantly affect the public health or significantly af-
fect the safety or supply or drinking water provided to
communities and individuals.
‘‘(d) FUNDING.—There are authorized to be appro-
priated to carry out this section not more than
$120,000,000 for the fiscal year 2002 and such sums as
may be necessary for fiscal year 2003 and fiscal year
2004. The Administrator, in coordination with State and
local governments, may provide financial assistance to
community water systems for purposes of compliance with
the requirements of subsections (a) and (b) and to commu-
nity water systems for expenses and contracts designed
to address basic security enhancements of critical impor-
tance and significant threats to public health and the sup-
ply of drinking water as determined by a vulnerability as-
sessment under subsection (a).
‘‘SEC. 1434. CONTAMINANT PREVENTION, DETECTION AND
RESPONSE.
‘‘(a) IN GENERAL.—The Administrator, in consulta-
tion with the Centers for Disease Control and, after con-
sultation with appropriate departments and agencies of
130
the Federal Government and with State and local govern-
ments, shall review (or enter into contracts or cooperative
agreements to provide for a review of) current and future
methods to prevent, detect and respond to the intentional
introduction of chemical, biological or radiological con-
taminants into community water systems and source
water for community water systems, including each of the
following:
‘‘(1) Methods, means and equipment designed
to monitor and detect chemical, biological, and radi-
ological contaminants and reduce the likelihood that
such contaminants can be successfully introduced
into water supplies intended to be used for drinking
water.
‘‘(2) Methods and means to provide sufficient
notice to operators of public water systems, and in-
dividuals served by such systems, of the introduction
of chemical, biological or radiological contaminants
and the possible effect of such introduction on public
health and the safety and supply of drinking water.
‘‘(3) Procedures and equipment necessary to
prevent the flow of contaminated drinking water to
individuals served by public water systems.
‘‘(4) Methods, means, and equipment which
could negate or mitigate deleterious effects on public
131
health and the safety and supply caused by the in-
troduction of contaminants into water intended to be
used for drinking water, including an examination of
the effectiveness of various drinking water tech-
nologies in removing, inactivating, or neutralizing bi-
ological, chemical, and radiological contaminants.
‘‘(5) Biomedical research into the short-term
and long-term impact on public health of various
chemical, biological and radiological contaminants
that may be introduced into public water systems
through terrorist of other intentional acts.
‘‘(b) FUNDING.—For the authorization of appropria-
tions to carry out this section, see section 1435(c).
‘‘SEC. 1435. SUPPLY DISRUPTION PREVENTION, DETECTION
AND RESPONSE.
‘‘(a) DISRUPTION OF SUPPLY OR SAFETY.—The Ad-
ministrator, in coordination with the appropriate depart-
ments and agencies of the Federal Government, shall re-
view (or enter into contracts or cooperative agreements to
provide for a review of) methods and means by which ter-
rorists or other individuals or groups could disrupt the
supply of safe drinking water or take other actions against
water collection, pretreatment, treatment, storage and dis-
tribution facilities which could render such water signifi-
132
cantly less safe for human consumption, including each
of the following:
‘‘(1) Methods and means by which pipes and
other constructed conveyances utilized in public
water systems could be destroyed or otherwise pre-
vented from providing adequate supplies of drinking
water meeting applicable public health standards.
‘‘(2) Methods and means by which collection,
pretreatment, treatment, storage and distribution fa-
cilities utilized or used in connection with public
water systems and collection and pretreatment stor-
age facilities used in connection with public water
systems could be destroyed or otherwise prevented
from providing adequate supplies of drinking water
meeting applicable public health standards.
‘‘(3) Methods and means by which pipes, con-
structed conveyances, collection, pretreatment, treat-
ment, storage and distribution systems that are uti-
lized in connection with public water systems could
be altered or affected so as to be subject to cross-
contamination of drinking water supplies.
‘‘(4) Methods and means by which pipes, con-
structed conveyances, collection, pretreatment, treat-
ment, storage and distribution systems that are uti-
lized in connection with public water systems could
133
be reasonably protected from terrorist attacks or
other acts intended to disrupt the supply or affect
the safety of drinking water.
‘‘(b) ALTERNATIVE SOURCES.—the review under this
section shall also include a review of the methods and
means by which alternative supplies of drinking water
could be provided in the event of the destruction, impair-
ment or contamination of public water systems.
‘‘(c) FUNDING.—There are authorized to be appro-
priated to carry out this section and section 1434 not
more than $15,000,000 for the fiscal year 2002 and such
sums as may be necessary for fiscal year 2003 and fiscal
year 2004.’’.
(2) Section 1414(i)(1) is amended by inserting
‘‘1433’’ after ‘‘1417’’.
(3) Section 1431 is amended by inserting in the
first sentence after ‘‘drinking water’’ the following:
‘‘, or that there is a threatened or potential terrorist
attack (or other intentional act designed to disrupt
the provision of safe drinking water or to impact ad-
versely the safety of drinking water supplied to com-
munities and individuals), which’’.
(4) Section 1432 is amended as follows:
(A) By striking ‘‘5 years’’ in subsection (a)
and inserting ‘‘20 years’’.
134
(B) By striking ‘‘3 years’’ in subsection (b)
and inserting ‘‘10 years’’.
(C) By striking ‘‘$50,000’’ in subsection
(c) and inserting ‘‘$1,000,000’’.
(D) By striking ‘‘$20,000’’ in subsection
(c) and inserting ‘‘$100,000’’.
(5) Section 1442 is amended as follows:
(A) By striking ‘‘this subparagraph’’ in
subsection (b) and inserting ‘‘this subsection’’.
(B) By amending subsection (d) to read as
follows:
‘‘(d) There are authorized to be appropriated to carry
out subsection (b) not more than $35,000,000 for the fis-
cal year 2002 and such sums as may be necessary for each
fiscal year thereafter.’’.
Passed the House of Representatives December 12,
2001.
Attest:
Clerk.
107TH CONGRESS
1ST SESSION
H. R. 3448
AN ACT
To improve the ability of the United States to pre-
vent, prepare for, and respond to bioterrorism
and other public health emergencies.