In the Senate of the United States,
December 20 (legislative day, December 18), 2001.
Resolved, That the bill from the House of Representa-
tives (H.R. 3448) entitled ‘‘An Act to improve the ability of
the United States to prevent, prepare for, and respond to bio-
terrorism and other public health emergencies.’’, do pass with
the following
AMENDMENT:
Strike out all after the enacting clause and insert:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the ‘‘Bio-
terrorism Preparedness Act of 2001’’.
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(b) TABLE OF CONTENTS.—The table of contents of the
Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I—NATIONAL GOALS FOR BIOTERRORISM PREPAREDNESS
Sec. 101. Amendment to the Public Health Service Act.
TITLE II—IMPROVING THE FEDERAL RESPONSE TO BIOTERRORISM
Subtitle A—Additional Authorities
Sec. 201. Additional authorities of the Secretary; Strategic National Pharma-
ceutical Stockpile.
Sec. 202. Improving the ability of the Centers for Disease Control and Prevention
to respond effectively to bioterrorism.
Subtitle B—Coordination of Efforts and Responses
Sec. 211. Assistant Secretary of Emergency Preparedness; National Disaster Med-
ical System.
Sec. 212. Expanded authority of the Secretary of Health and Human Services to
respond to public health emergencies.
Sec. 213. Public health preparedness and response to a bioterrorist attack.
Sec. 214. The official Federal Internet site on bioterrorism.
Sec. 215. Technical amendments.
Sec. 216. Regulation of biological agents and toxins.
TITLE III—IMPROVING STATE AND LOCAL PREPAREDNESS
Subtitle A—Emergency Measures To Improve State and Local Preparedness
Sec. 301. State bioterrorism preparedness and response block grant.
Subtitle B—Improving Local Preparedness and Response Capabilities
Sec. 311. Designated bioterrorism response medical centers.
Sec. 312. Designated State public emergency announcement plan.
Sec. 313. Training for pediatric issues surrounding biological agents used in war-
fare and terrorism.
Sec. 314. General Accounting Office report.
Sec. 315. Additional research.
Sec. 316. Sense of the Senate.
TITLE IV—DEVELOPING NEW COUNTERMEASURES AGAINST
BIOTERRORISM
Sec. 401. Limited antitrust exemption.
Sec. 402. Developing new countermeasures against bioterrorism.
Sec. 403. Sequencing of priority pathogens.
Sec. 404. Accelerated countermeasure research and development.
Sec. 405. Accelerated approval of priority countermeasures.
Sec. 406. Use of animal trials in the approval of priority countermeasures.
Sec. 407. Miscellaneous provisions.
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TITLE V—PROTECTING THE SAFETY AND SECURITY OF THE FOOD
SUPPLY
Subtitle A—General Provisions To Expand and Upgrade Security
Sec. 511. Food safety and security strategy.
Sec. 512. Expansion of Animal and Plant Health Inspection Service activities.
Sec. 513. Expansion of Food Safety Inspection Service activities.
Sec. 514. Expansion of Food and Drug Administration activities.
Sec. 515. Biosecurity upgrades at the Department of Agriculture.
Sec. 516. Biosecurity upgrades at the Department of Health and Human Serv-
ices.
Sec. 517. Agricultural biosecurity.
Sec. 518. Biosecurity of food manufacturing, processing, and distribution.
Subtitle B—Protection of the Food Supply
Sec. 531. Administrative detention.
Sec. 532. Debarment for repeated or serious food import violations.
Sec. 533. Maintenance and inspection of records for foods.
Sec. 534. Registration of food manufacturing, processing, and handling facilities.
Sec. 535. Prior notice of imported food shipments.
Sec. 536. Authority to mark refused articles.
Sec. 537. Authority to commission other Federal officials to conduct inspections.
Sec. 538. Prohibition against port shopping.
Sec. 539. Grants to States for inspections.
Sec. 540. Rule of construction.
Subtitle C—Research and Training To Enhance Food Safety and Security
Sec. 541. Surveillance and information grants and authorities.
Sec. 542. Agricultural bioterrorism research and development.
TITLE I—NATIONAL GOALS FOR
BIOTERRORISM PREPAREDNESS
SEC. 101. AMENDMENT TO THE PUBLIC HEALTH SERVICE
ACT.
The Public Health Service Act (42 U.S.C. 201 et seq.)
is amended by adding at the end the following:
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‘‘TITLE XXVIII—STRENGTHENING
THE 
NATION’S 
PREPARED-
NESS FOR BIOTERRORISM
‘‘SEC. 2801. CONGRESSIONAL FINDINGS ON BIOTERRORISM
PREPAREDNESS.
‘‘Congress finds that the United States should further
develop and implement a coordinated strategy to prevent,
and if necessary, to respond to biological threats or attacks
upon the United States. Such strategy should include meas-
ures for—
‘‘(1) enabling the Federal Government to provide
health care assistance to States and localities in the
event of a biological threat or attack;
‘‘(2) improving public health, hospital, labora-
tory, communications, and emergency response per-
sonnel preparedness and responsiveness at the State
and local levels;
‘‘(3) rapidly developing and manufacturing
needed therapies, vaccines, and medical supplies; and
‘‘(4) enhancing the protection of the nation’s food
supply and protecting agriculture against biological
threats or attacks.’’.
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TITLE II—IMPROVING THE FED-
ERAL RESPONSE TO BIOTER-
RORISM
Subtitle A—Additional Authorities
SEC. 201. ADDITIONAL AUTHORITIES OF THE SECRETARY;
STRATEGIC 
NATIONAL 
PHARMACEUTICAL
STOCKPILE.
Title XXVIII of the Public Health Service Act, as
added by section 101, is amended by adding at the end the
following:
‘‘Subtitle A—Improving the Federal
Response to Bioterrorism
‘‘SEC. 2811. AUTHORITY OF THE SECRETARY RELATED TO
BIOTERRORISM PREPAREDNESS.
‘‘(a) PLAN.—To meet the objectives of this title (and
the amendments made by the Bioterrorism Preparedness
Act of 2001), and to help the United States fully prepare
for a biological threat or attack, the Secretary, consistent
with the recommendations and activities of the working
group established under section 319F(a), shall develop and
implement a coordinated plan to meet such objectives that
are within the jurisdiction of the Secretary. Such plan shall
include the development of specific criteria that will enable
measurements to be made of the progress made at the na-
tional, State, and local levels toward achieving the national
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goal of bioterrorism preparedness, including actions to
strengthen the preparedness of rural communities for a bio-
logical threat or attack.
‘‘(b) BIENNIAL REPORTS.—
‘‘(1) IN GENERAL.—Not later than 1 year after
the date of enactment of this title, and biennially
thereafter, the Secretary shall prepare and submit to
Congress a report concerning the progress made and
the steps taken by the Secretary to further the pur-
poses of this title (and the amendments made by the
Bioterrorism Preparedness Act of 2001). Such report
shall include an assessment of the activities conducted
under section 319F(c).
‘‘(2) ADDITIONAL AUTHORITY.—In the biennial
report submitted under paragraph (1), the Secretary
may make recommendations concerning—
‘‘(A) additional legislative authority that
the Secretary determines is necessary to meet the
objectives of this title (and the amendments made
by the Bioterrorism Preparedness Act of 2001);
and
‘‘(B) additional legislative authority that
the Secretary determines is necessary under sec-
tion 319 to protect the public health in the event
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that a condition described in section 319(a) oc-
curs.
‘‘(c) OTHER REPORTS.—Not later than 1 year after
the date of enactment of this title, the Secretary shall pre-
pare and submit to Congress a report concerning—
‘‘(1) activities conducted under section 319F(b);
‘‘(2) the characteristics that may render a rural
community uniquely vulnerable to a biological threat
or attack, including distance, lack of emergency trans-
port, hospital or laboratory capacity, lack of integra-
tion of Federal or State public health networks, work-
force deficits, or other relevant conditions;
‘‘(3) in any case in which the Secretary deter-
mines that additional legislative authority is nec-
essary to effectively strengthen the preparedness of
rural communities for responding to a biological
threat or attack, the recommendations of the Sec-
retary with respect to such legislative authority; and
‘‘(4) the need for and benefits of a National Dis-
aster Response Medical Volunteer Service that would
be a private-sector, community-based rapid response
corps of medical volunteers.
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‘‘SEC. 
2812. 
STRATEGIC 
NATIONAL 
PHARMACEUTICAL
STOCKPILE.
‘‘(a) IN GENERAL.—The Secretary, in coordination
with the Secretary of Veterans Affairs, shall maintain a
strategic stockpile of vaccines, therapies, and medical sup-
plies that are adequate, as determined by the Secretary, to
meet the health needs of the United States population, in-
cluding children and other vulnerable populations, for use
at the direction of the Secretary, in the event of a biological
threat or attack or other public health emergency.
‘‘(b) RULE OF CONSTRUCTION.—Nothing in subsection
(a) shall be construed to prohibit the Secretary from includ-
ing in the stockpile described in such subsection such vac-
cines, therapies, or medical supplies as may be necessary
to meet the needs of the United States in the event of a
nuclear, radiological, or chemical attack or other public
health emergency.
‘‘(c) DEFINITION.—In this section, the term ‘stockpile’
means—
‘‘(1) a physical accumulation of the material de-
scribed 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
such medical supplies as shall be described in the con-
tract at such time as shall be specified in the contract.
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‘‘(d) PROCEDURES.—The Secretary, in managing the
stockpile under this section, shall—
‘‘(1) ensure that adequate procedures are followed
with respect to the stockpile maintained under sub-
section (a) for inventory management, accounting,
and for the physical security of such stockpile; and
‘‘(2) in consultation with State and local offi-
cials, take into consideration the timing and location
of special events, including designated national secu-
rity events.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section,
$640,000,000 for fiscal year 2002, and such sums as may
be necessary for each of fiscal years 2003 through 2006.’’.
SEC. 202. IMPROVING THE ABILITY OF THE CENTERS FOR
DISEASE CONTROL AND PREVENTION TO RE-
SPOND EFFECTIVELY TO BIOTERRORISM.
(a) REVITALIZING THE CDC.—Section 319D of the
Public Health Service Act (42 U.S.C. 247d–4) is
amended—
(1) in subsection (a), by inserting ‘‘, and ex-
panded, enhanced, and improved capabilities of the
Centers related to biological threats or attacks,’’ after
‘‘modern facilities’’;
(2) in subsection (b)—
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(A) by inserting ‘‘, including preparing for
or responding to biological threats or attacks,’’
after ‘‘public health activities’’; and
(B) by inserting ‘‘$60,000,000 for fiscal
year 2002,’’; and
(3) by adding at the end the following:
‘‘(c) IMPROVING PUBLIC HEALTH LABORATORY CA-
PACITY.—
‘‘(1) IN GENERAL.—The Secretary shall provide
for the establishment of a coordinated network of pub-
lic health laboratories to assist with the detection of
and response to a biological threat or attack, that
may, at the discretion of the Secretary, include lab-
oratories that serve as regional reference laboratories.
‘‘(2) AUTHORITY.—The Secretary may award
grants, contracts, or cooperative agreements to carry
out paragraph (1).
‘‘(3) COORDINATION.—To the maximum extent
practicable, the Secretary shall ensure that activities
conducted under paragraph (1) are coordinated with
existing laboratory preparedness activities.
‘‘(4) LOCAL DISCRETION.—Use of regional lab-
oratories, if established under paragraph (1), shall be
at the discretion of the public health agencies of the
States.
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‘‘(5) PROHIBITED USES.—An eligible entity may
not use amounts received under this subsection to—
‘‘(A) purchase or improve land or purchase
any building or other facility; or
‘‘(B) construct, repair, or alter any building
or other facility.
‘‘(6) SUPPLEMENT NOT SUPPLANT.—Funds ap-
propriated under this subsection shall be used to sup-
plement and not supplant other Federal, State, and
local public funds provided for activities under this
subsection.
‘‘(7) AUTHORIZATION
OF
APPROPRIATIONS.—
There is authorized to be appropriated to carry out
this subsection, $59,500,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years
2003 through 2006.’’.
(b) EDUCATION AND TRAINING.—Section 319F(e) of
the Public Health Service Act (42 U.S.C. 247d6(e)) is
amended by adding at the end the following flush sentence:
‘‘The education and training activities described in this
subsection may be carried out through Public Health Pre-
paredness Centers, Noble training facilities, the Emerging
Infections Program, and the Epidemic Intelligence Serv-
ice.’’.
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Subtitle B—Coordination of Efforts
and Responses
SEC. 211. ASSISTANT SECRETARY FOR EMERGENCY PRE-
PAREDNESS; NATIONAL DISASTER MEDICAL
SYSTEM.
Title XXVIII of the Public Health Service Act, as
added by section 101, and amended by section 201, is fur-
ther amended by adding at the end the following:
‘‘SEC. 2813. ASSISTANT SECRETARY FOR EMERGENCY PRE-
PAREDNESS.
‘‘(a) APPOINTMENT OF ASSISTANT SECRETARY FOR
EMERGENCY PREPAREDNESS.—The President, with the ad-
vice and consent of the Senate, shall appoint an individual
to serve as the Assistant Secretary for Emergency Prepared-
ness who shall head the Office for Emergency Preparedness.
Such Assistant Secretary shall report to the Secretary.
‘‘(b) DUTIES.—Subject to the authority of the Sec-
retary, the Assistant Secretary for Emergency Preparedness
shall—
‘‘(1) serve as the principal adviser to the Sec-
retary on matters relating to emergency preparedness,
including preparing for and responding to biological
threats or attacks and for developing policy; and
‘‘(2) coordinate all functions within the Depart-
ment of Health and Human Services relating to
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emergency preparedness, including preparing for and
responding to biological threats or attacks.
‘‘SEC. 2814. NATIONAL DISASTER MEDICAL SYSTEM.
‘‘(a) NATIONAL DISASTER MEDICAL SYSTEM.—
‘‘(1) IN GENERAL.—There shall be operated a
system to be known as the National Disaster Medical
System (in this section referred to as the ‘National
System’) which shall be coordinated by the Secretary,
in collaboration with the Secretary of Defense, the
Secretary of Veterans Affairs, and the Director of the
Federal Emergency Management Agency.
‘‘(2) FUNCTIONS.—The National System shall
provide appropriate health services, health-related so-
cial services and, if necessary, auxiliary services (in-
cluding mortuary and veterinary services) to respond
to the needs of victims of a public health emergency
if the Secretary activates the System with respect to
the emergency. The National System shall carry out
such ongoing activities as may be necessary to pre-
pare for the provision of such services.
‘‘(b) 
TEMPORARY
DISASTER-RESPONSE
PER-
SONNEL.—
‘‘(1) IN GENERAL.—For the purpose of assisting
the Office of Emergency Preparedness and the Na-
tional System in carrying out duties under this sec-
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tion, the Secretary may in accordance with section
316.401 of title 5, Code of Federal Regulations (in-
cluding revisions to such section), and notwith-
standing the eligibility requirements set forth in
paragraphs (1) through (8) of section 316.402(b) of
such title (including revisions), make temporary ap-
pointments of individuals to intermittent positions to
serve as personnel of such Office or System.
‘‘(2) TRAVEL AND SUBSISTENCE.—An individual
appointed under paragraph (1) shall, in accordance
with subchapter I of chapter 57 of title 5, United
States Code, be eligible for travel, subsistence, and
other necessary expenses incurred in carrying out the
duties for which the individual was appointed, in-
cluding per diem in lieu of subsistence.
‘‘(3) LIABILITY.—For purposes of section 224(a)
and the remedies described in such section, an indi-
vidual appointed under paragraph (1) shall, while
acting within the scope of such appointment, be con-
sidered to be an employee of the Public Health Service
performing medical, surgical, dental, or related func-
tions. Participation in training programs carried out
by the Office of Emergency Preparedness or Federal
personnel of the National System shall be considered
within the scope of such an appointment (regardless
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of whether the individual receives compensation for
such participation).
‘‘(c) TEMPORARY DISASTER-RESPONSE APPOINTEE.—
For purposes of this section, the term ‘temporary disaster-
response appointee’ means an individual appointed by the
Secretary under subsection (b).
‘‘(d) COMPENSATION FOR WORK INJURIES.—A tem-
porary disaster-response appointee, as designated by the
Secretary, shall be deemed an employee, and an injury sus-
tained by such an individual while actually serving or
while participating in a uncompensated training exercise
related to such service 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. In the
event of an injury to such a temporary disaster-response
appointee, the Secretary of Labor shall be responsible for
making determinations as to whether the claimants are en-
titled to compensation or other benefits in accordance with
chapter 81 of title 5, United States Code.
‘‘(e) EMPLOYMENT AND REEMPLOYMENT RIGHTS.—
‘‘(1) IN
GENERAL.—A temporary disaster-re-
sponse appointee, as designated by the Secretary,
shall, when performing service as a temporary dis-
aster-response appointee or participating in an un-
compensated training exercise related to such service,
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be deemed a person performing ‘service in the uni-
formed services’ for purposes of chapter 43 of title 38,
United States Code, pertaining to employment and
reemployment rights of members in the uniformed
services. All rights and obligations of such persons
and procedures for assistance, enforcement, and inves-
tigation shall be as provided for in chapter 43 of title
38, United States Code.
‘‘(2) NOTICE OF ABSENCE FROM POSITION OF
EMPLOYMENT.—Preclusion of giving notice of service
by disaster response necessity shall be deemed pre-
clusion by ‘military necessity’ for purposes of section
4312(b) of title 38, United States Code, pertaining to
giving notice of absence from a position of employ-
ment. A determination of disaster response necessity
shall be made pursuant to regulations prescribed by
the Secretary, in consultation with the Secretary of
Defense, and shall not be subject to judicial review.
‘‘(f) LIMITATION.—A temporary disaster-response ap-
pointee shall not be deemed an employee of the Public
Health Service or the Office of Emergency Preparedness for
purposes other than those specifically set forth in this sec-
tion.’’.
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SEC. 212. EXPANDED AUTHORITY OF THE SECRETARY OF
HEALTH AND HUMAN SERVICES TO RESPOND
TO PUBLIC HEALTH EMERGENCIES.
(a) PROVISION OF DECLARATION TO CONGRESS.—Sec-
tion 319(a) of the Public Health Service Act (42 U.S.C.
247d(a)) is amended by adding at the end the following:
‘‘Not later than 48 hours after a declaration of a public
health emergency under this section, the Secretary shall pro-
vide a written declaration to Congress indicating that an
emergency under this section has been declared.’’.
(b) WAIVER OF REPORTING DEADLINES.—Section 319
of the Public Health Service Act (42 U.S.C. 247d) is amend-
ed by adding at the end the following:
‘‘(d) WAIVER OF DATA SUBMITTAL AND REPORTING
DEADLINES.—In any case in which the Secretary deter-
mines 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 any sanctions otherwise applicable to such failure to
comply.’’.
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(c) EMERGENCY DECLARATION PERIOD.—Section 319
of the Public Health Service Act (42 U.S.C. 247d), as
amended by subsection (b), is further amended by adding
at the end the following:
‘‘(e) EMERGENCY DECLARATION PERIOD.—A deter-
mination by the Secretary under subsection (a) that a pub-
lic health emergency exists shall remain in effect for not
longer than the 180-day period beginning on the date of
the determination. Such period may be extended by the Sec-
retary if—
‘‘(1) the Secretary determines that such an exten-
sion is appropriate; and
‘‘(2) the Secretary provides a written notifica-
tion to Congress within 48 hours of such extension.’’.
SEC. 213. PUBLIC HEALTH PREPAREDNESS AND RESPONSE
TO A BIOTERRORIST ATTACK.
Section 319F of the Public Health Service Act (42
U.S.C. 247d–6) is amended by striking subsections (a) and
(b), and inserting the following:
‘‘(a) WORKING GROUP ON BIOTERRORISM.—The Sec-
retary, in coordination with the Secretary of Defense, the
Director of the Federal Emergency Management Agency, the
Attorney General, the Secretary of Veterans Affairs, the Sec-
retary of Labor, and the Secretary of Agriculture, and with
other similar Federal officials as determined appropriate,
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shall establish a joint interdepartmental working group on
the prevention, preparedness, and response to a biological
threat or attack on the civilian population. Such joint
working group shall—
‘‘(1) prioritize countermeasures required to treat,
prevent, or identify exposure to a biological agent or
toxin pursuant to section 351A;
‘‘(2) coordinate and facilitate the awarding of
grants, contracts, or cooperative agreements for the
development, manufacture, distribution, and purchase
of priority countermeasures;
‘‘(3) coordinate research on pathogens likely to be
used in a biological threat or attack on the civilian
population;
‘‘(4) develop shared standards for equipment to
detect and to protect against biological agents and
toxins;
‘‘(5) coordinate the development, maintenance,
and procedures for the release of materials from the
Strategic National Pharmaceutical Stockpile;
‘‘(6) assess the priorities for and enhance the
preparedness of public health institutions, providers
of medical care, and other emergency service per-
sonnel (including firefighters) to detect, diagnose, and
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The working group shall carry out paragraphs (1) and (2)
in consultation with the pharmaceutical, biotechnology, and
medical device industries, and other appropriate experts.
‘‘(b) ADVICE
TO
THE SECRETARY.—The Secretary
shall establish advisory committees to provide expert rec-
ommendations to the Secretary to assist the Secretary, in-
cluding the following:
‘‘(1) NATIONAL TASK FORCE ON CHILDREN AND
TERRORISM.—
‘‘(A) IN
GENERAL.—The National Task
Force on Children and Terrorism, which shall be
composed of such Federal officials as may be ap-
propriate to address the special needs of children,
and child health experts on infectious disease, en-
vironmental health, toxicology, and other rel-
evant professional disciplines.
‘‘(B) DUTIES.—The task force described in
subparagraph (A) shall provide recommenda-
tions to the Secretary regarding—
‘‘(i) the preparedness of the health care
system to respond to bioterrorism as it re-
lates to children;
‘‘(ii) needed changes to the health care
and emergency medical service systems and
emergency medical services protocols to meet
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the special needs of children with respect to
a biological threat or attack; and
‘‘(iii) changes, if necessary, to the
Strategic National Pharmaceutical Stock-
pile, to meet the special needs of children.
‘‘(2) EMERGENCY
PUBLIC
INFORMATION
AND
COMMUNICATIONS TASK FORCE.—
‘‘(A) IN GENERAL.—The Emergency Public
Information and Communications (EPIC) Task
Force, which shall be composed of individuals
with expertise in public health, communications,
behavioral psychology, and other areas deter-
mined appropriate by the Secretary.
‘‘(B) DUTIES.—The task force described in
subparagraph (A) shall make recommendations
and report to the Secretary on appropriate ways
to communicate information regarding biological
threats or attacks to the public, including public
service announcements or other appropriate
means to communicate in a manner that maxi-
mizes information and minimizes panic, and in-
cludes information relevant to children and other
vulnerable populations.
‘‘(3) SUNSET.—Each Task Force established
under paragraphs (1) and (2) shall terminate on the
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date that is 1 year after the date of enactment of the
Bioterrorism Preparedness Act of 2001.’’.
SEC. 214. THE OFFICIAL FEDERAL INTERNET SITE ON BIO-
TERRORISM.
It is the recommendation of Congress that there should
be established an official Federal Internet site on bioter-
rorism, either directly or through provision of a grant to
an entity that has expertise in bioterrorism and the develop-
ment of websites, that should include information relevant
to diverse populations (including messages directed at the
general public and such relevant groups as medical per-
sonnel, public safety workers, and agricultural workers) and
links to appropriate State and local government sites.
SEC. 215. TECHNICAL AMENDMENTS.
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 (f), by inserting ‘‘$420,000,000
for fiscal year 2002,’’ after ‘‘2001,’’.
SEC. 216. REGULATION OF BIOLOGICAL AGENTS AND TOX-
INS.
(a) BIOLOGICAL
AGENTS
PROVISIONS
OF
THE
ANTITERRORISM AND EFFECTIVE DEATH PENALTY ACT OF
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1996; CODIFICATION IN THE PUBLIC HEALTH SERVICE
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 BIOLOGICAL AGENTS
AND TOXINS.
‘‘(a) REGULATORY CONTROL OF BIOLOGICAL 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 sub-
paragraph (A), the Secretary shall—
‘‘(i) consider—
‘‘(I) the effect on human health of
exposure to the agent or toxin;
‘‘(II) the degree of contagiousness
of the agent or toxin and the methods
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by which the agent or toxin is trans-
ferred to humans;
‘‘(III) the availability and effec-
tiveness of pharmacotherapies and im-
munizations to treat and prevent any
illness resulting from infection by the
agent or toxin; and
‘‘(IV) any other criteria, includ-
ing the needs of children and other vul-
nerable populations, that the Secretary
considers appropriate; and
‘‘(ii) consult with appropriate Federal
departments and agencies, and scientific ex-
perts representing appropriate professional
groups, including those with pediatric ex-
pertise.
‘‘(2) BIENNIAL REVIEW.—The Secretary shall re-
view and republish the list under paragraph (1) bien-
nially, or more often as needed, and shall, through
rulemaking, revise the list as necessary to incorporate
additions or deletions to ensure public health, safety,
and security.
‘‘(3) EXEMPTIONS.—The Secretary may exempt
from the list under paragraph (1)—
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‘‘(A) attenuated or inactive biological
agents or toxins used in biomedical research or
for legitimate medical purposes; and
‘‘(B) products that are cleared or approved
under the Federal Food, Drug, and Cosmetic Act
or under the Virus-Serum-Toxin Act, as amend-
ed in 1985 by the Food Safety and Security
Act.’’;
‘‘(b) REGULATION OF TRANSFERS OF LISTED BIO-
LOGICAL AGENTS AND TOXINS.—The Secretary shall by reg-
ulation provide for—
‘‘(1) the establishment and enforcement of safety
procedures for the transfer of biological agents and
toxins listed pursuant to subsection (a)(1), including
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 international ter-
rorism 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 violation
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of the safety procedures established under paragraph
(1) or the safeguards established under paragraph (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 standards
and procedures governing the possession and use of biologi-
cal agents and toxins listed pursuant to subsection (a)(1)
in order to protect the public health and safety, including
the measures, safeguards, procedures, and availability of
such agents and toxins described in paragraphs (1) through
(4) of subsection (b), respectively.
‘‘(d) REGISTRATION
AND
TRACEABILITY
MECHA-
NISMS.—Regulations under subsections (b) and (c) shall re-
quire registration for the possession, use, and transfer of
biological agents and toxins listed pursuant to subsection
(a)(1), and such registration shall include (if available to
the registered person) information regarding the character-
ization of such biological agents and toxins to facilitate
their identification and traceability. The Secretary shall
maintain a national database of the location of such bio-
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logical agents and toxins with information regarding their
characterizations.
‘‘(e) INSPECTIONS.—The Secretary shall have the au-
thority to inspect persons subject to the regulations under
subsections (b) and (c) to ensure their compliance with such
regulations, including prohibitions on restricted persons
under subsection (g).
‘‘(f) EXEMPTIONS.—
‘‘(1) IN GENERAL.—The Secretary shall establish
exemptions, including exemptions from the security
provisions, from the applicability of provisions of—
‘‘(A) the regulations issued under sub-
sections (b) and (c) when the Secretary deter-
mines that the exemptions, including exemptions
from the security requirements for the use of at-
tenuated or inactive biological agents or toxins
in biomedical research or for legitimate medical
purposes, are consistent with protecting public
health and safety; and
‘‘(B) the regulations issued under subsection
(c).
‘‘(2) CLINICAL
LABORATORIES.—The Secretary
shall exempt clinical laboratories and other persons
that possess, use, or transfer biological agents and tox-
ins listed pursuant to subsection (a)(1) from the ap-
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plicability of provisions of regulations issued under
subsections (b) and (c) only when—
‘‘(A) such agents or toxins are presented for
diagnosis, verification, or proficiency testing;
‘‘(B) the identification of such agents and
toxins is, when required under Federal or State
law, reported to the Secretary or other public
health authorities; and
‘‘(C) such agents or toxins are transferred
or destroyed in a manner set forth by the Sec-
retary in regulation.
‘‘(g) SECURITY REQUIREMENTS
FOR REGISTERED
PERSONS.—
‘‘(1) SECURITY.—In carrying out paragraphs
(2) and (3) of subsection (b), the Secretary shall es-
tablish appropriate security requirements for persons
possessing, using, or transferring biological agents
and toxins listed pursuant to subsection (a)(1), con-
sidering existing standards developed by the Attorney
General for the security of government facilities, and
shall ensure compliance with such requirements as a
condition of registration under regulations issued
under subsections (b) and (c).
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‘‘(2) LIMITING ACCESS TO LISTED AGENTS AND
TOXINS.—Regulations issued under subsections (b)
and (c) shall include provisions—
‘‘(A) to restrict access to biological agents
and toxins listed pursuant to subsection (a)(1)
only to those individuals who need to handle or
use such agents or toxins; and
‘‘(B) to provide that registered persons
promptly submit the names and other identi-
fying information for such individuals to the At-
torney General, with which information the At-
torney General shall promptly use criminal, im-
migration, and national security databases
available to the Federal Government to identify
whether such individuals—
‘‘(i) are restricted persons, as defined
in section 175b of title 18, United States
Code; or
‘‘(ii) are named in a warrant issued to
a Federal or State law enforcement agency
for participation in any domestic or inter-
national act of terrorism.
‘‘(3) CONSULTATION
AND
IMPLEMENTATION.—
Regulations under subsections (b) and (c) shall be de-
veloped in consultation with research-performing or-
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ganizations, including universities, and implemented
with timeframes that take into account the need to
continue research and education using biological
agents and toxins listed pursuant to subsection (a)(1).
‘‘(h) DISCLOSURE OF INFORMATION.—
‘‘(1) IN GENERAL.—Any information in the pos-
session of any Federal agency that identifies a person,
or the geographic location of a person, who is reg-
istered pursuant to regulations under this section (in-
cluding regulations promulgated before the effective
date of this subsection), or any site-specific informa-
tion relating to the type, quantity, or characterization
of a biological agent or toxin listed pursuant to sub-
section (a)(1) or the site-specific security mechanisms
in place to protect such agents and toxins, including
the national database required in subsection (d), 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
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‘‘(B) from making disclosures of such infor-
mation to any committee or subcommittee of the
Congress with appropriate jurisdiction, upon re-
quest.
‘‘(i) CIVIL MONEY PENALTY.—Any person who violates
a regulation under subsection (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. The provisions
of section 1128A of the Social Security Act (other than sub-
sections (a), (b), (h), and (i), the first sentence of subsection
(c), and paragraphs (1) and (2) of subsection (f) of such
section) shall apply to civil money penalties under this sub-
section 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 section in
the same manner as provided in section 1128A(j)(2) of such
Act and such authority shall include all powers described
in section 6 of the Inspector General Act of 1978 (5 U.S.C.
App. 2)
‘‘(j) DEFINITIONS.—For purposes of this section, the
terms ‘biological agent’ and ‘toxin’ have the same meaning
as in section 178 of title 18, United States Code.’’.
(2) REGULATIONS.—
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(A) DATE
CERTAIN
FOR
PROMULGATION;
EFFECTIVE
DATE
REGARDING
CRIMINAL
AND
CIVIL PENALTIES.—Not later than 180 days after
the date of the enactment of this title, the Sec-
retary of Health and Human Services shall pro-
mulgate an interim final rule for carrying out
section 351A(c) of the Public Health Service Act,
which amends the Antiterrorism and Effective
Death Penalty Act of 1996. Such interim final
rule will take effect 60 days after the date on
which such rule is promulgated, including for
purposes of—
(i) section 175(b) of title 18, United
States Code (relating to criminal penalties),
as added by subsection (b)(1)(B) of this sec-
tion; and
(ii) section 351A(i) of the Public
Health Service Act (relating to civil pen-
alties).
(B) SUBMISSION OF REGISTRATION APPLI-
CATIONS.—A person required to register for pos-
session under the interim final rule promulgated
under subparagraph (A) shall submit an appli-
cation for such registration not later than 60
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days after the date on which such rule is promul-
gated.
(3) CONFORMING AMENDMENT.—Subsections (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.
(4) EFFECTIVE DATE.—Paragraph (1) shall take
effect as if incorporated in the Antiterrorism and Ef-
fective Death Penalty Act of 1996, and any regula-
tions, including the list under subsection (d)(1) of sec-
tion 511 of that Act, issued under section 511 of that
Act shall remain in effect as if issued under section
351A of the Public Health Service Act.
(b) SELECT AGENTS.—
(1) IN
GENERAL.—Section 175 of title 18,
United States Code, as amended by the Uniting and
Strengthening America by Providing Appropriate
Tools Required to Intercept and Obstruct Terrorism
(USA PATRIOT ACT) Act of 2001 (Public Law 107–
56), is amended—
(A) by redesignating subsections (b) and (c)
as subsections (c) and (d), respectively; and
(B) by inserting after subsection (a) the fol-
lowing:
‘‘(b) SELECT AGENTS.—
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‘‘(1) 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
regulation issued 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) TRANSFER TO UNREGISTERED PERSON.—
Whoever transfers a select agent to a person who the
transferor has reason to believe has not obtained a
registration required by regulations issued under sec-
tion 351A(b) or (c) of the Public Health Service Act
shall be fined under this title, or imprisoned for not
more than 5 years, or both.’’.
(2) DEFINITIONS.—Section 175 of title 18,
United States Code, as amended by paragraph (1), is
further amended by striking subsection (d) and in-
serting the following:
‘‘(d) DEFINITIONS.—As used in this section:
‘‘(1) The terms ‘biological agent’ and ‘toxin’ have
the meanings given such terms in section 178, except
that, for purposes of subsections (b) and (c), such
terms do not encompass any biological agent or toxin
that is in its naturally occurring environment, if the
biological agent or toxin has not been cultivated, cul-
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tured, collected, or otherwise extracted from its nat-
ural source.
‘‘(2) The term ‘for use as a weapon’ includes the
development, production, transfer, acquisition, reten-
tion, or possession of any biological agent, toxin, or
delivery system, other than for prophylactic, protec-
tive, or other peaceful purposes.
‘‘(3) The term ‘select agent’ means a biological
agent or toxin, as defined in paragraph (1), that is
on the list that is in effect pursuant to section
511(d)(1) of the Antiterrorism and Effective Death
Penalty Act of 1996 (Public Law 104–132), or as sub-
sequently revised under section 351A(a) of the Public
Health Service Act.’’.
(3) CONFORMING AMENDMENT.—
(A) Section 175(a) of title 18, United States
Code, is amended in the second sentence by strik-
ing ‘‘under this section’’ and inserting ‘‘under
this subsection’’.
(B) Section 175(c) of title 18, United States
Code, (as redesignated by paragraph (1)), is
amended by striking the second sentence.
(c) 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
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other appropriate Federal agencies, shall submit to the Con-
gress 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 Pub-
lic Health Service Act, including the extent of compli-
ance before the date of the enactment of this Act, and
including the extent of compliance with regulations
promulgated after such date of enactment;
(2) describes the actions to date and future plans
of the Secretary for updating the list of biological
agents and toxins under section 351A(a)(1) of the
Public Health Service Act;
(3) describes the actions to date and future plans
of the Secretary for determining compliance with reg-
ulations under such section 351A of the Public Health
Service Act 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 of the Public Health Serv-
ice Act.
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TITLE III—IMPROVING STATE
AND LOCAL PREPAREDNESS
Subtitle A—Emergency Measures to
Improve State and Local Pre-
paredness
SEC. 301. STATE BIOTERRORISM PREPAREDNESS AND RE-
SPONSE BLOCK GRANT.
(a) IN GENERAL.—Section 319F of the Public Health
Service Act (42 U.S.C. 247d–6) is amended by striking sub-
section (c) and inserting the following:
‘‘(c) STATE BIOTERRORISM PREPAREDNESS AND RE-
SPONSE BLOCK GRANTS.—
‘‘(1) IN GENERAL.—The Secretary shall establish
the State Bioterrorism Preparedness and Response
Block Grant Program (referred to in this subsection
as the ‘Program’) under which the Secretary shall
award grants to or enter into cooperative agreements
with States, the District of Columbia, and territories
(referred to in this section as ‘eligible entities’) to en-
able such entities to prepare for and respond to bio-
logical threats or attacks. The Secretary shall ensure
that activities conducted under this section are co-
ordinated with the activities conducted under this sec-
tion and section 319C.
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‘‘(2) ELIGIBILITY.—To be eligible to receive
amounts under paragraph (1), a State, the District of
Columbia, or a territory shall prepare and submit to
the Secretary an application at such time, in such
manner, and containing such information as the Sec-
retary may require, including an assurance that the
entity will—
‘‘(A) not later than 180 days after the date
on which a grant or contract is received under
this subsection, prepare and submit to the Sec-
retary a Bioterrorism Preparedness and Re-
sponse Plan in accordance with subsection (c);
‘‘(B) not later than 180 days after the date
on which a grant or contract is received under
this subsection, complete an assessment under
section 319B(a), or an assessment that is sub-
stantially equivalent as determined by the Sec-
retary unless such assessment has already been
performed; and
‘‘(C) establish a means by which to obtain
public comment and input on the plan and plan
implementation that shall include an advisory
committee or other similar mechanism for ob-
taining input from the public at large as well as
other stakeholders;
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‘‘(D) use amounts received under paragraph
(1) in accordance with the plan submitted under
paragraph (3), including making expenditures to
carry out the strategy contained in the plan;
‘‘(E) use amounts received under paragraph
(1) to supplement and not supplant funding at
levels in existence prior to September 11, 2001
for public health capacities or bioterrorism pre-
paredness; and
‘‘(F) with respect to the plan under para-
graph (3), establish reasonable criteria to evalu-
ate the effective performance of entities that re-
ceive funds under the grant or agreement and
shall include relevant benchmarks in the plan.
‘‘(3) BIOTERRORISM
PREPAREDNESS
AND
RE-
SPONSE PLAN.—Not later than 180 days after receiv-
ing amounts under this subsection, and 1 year after
such date, a State, the District of Columbia, or a ter-
ritory shall prepare and submit to the Secretary a
Bioterrorism Preparedness and Response Plan for re-
sponding to biological threats or attacks. Recognizing
the assessment of public health capacity conducted
under section 319B, such plan shall include—
‘‘(A) a description of the program that the
eligible entity will adopt to achieve the core ca-
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pacities developed under section 319A, including
measures that meet the needs of children and
other vulnerable populations;
‘‘(B) a description (including amounts ex-
pended by the eligible entity for such purpose) of
the programs, projects, and activities that the el-
igible entity will implement using amounts re-
ceived in order to detect and respond to biologi-
cal threats or attacks, including the manner in
which the eligible entity will manage State sur-
veillance and response efforts and coordinate
such efforts with national efforts;
‘‘(C) a description of the training initia-
tives that the eligible entity has carried out to
improve its ability to detect and respond to a bi-
ological threat or attack, including training and
planning to protect the health and safety of those
conducting such detection and response activi-
ties;
‘‘(D) a description of the cleanup and con-
tamination prevention efforts that may be imple-
mented in the event of a biological threat or at-
tack;
‘‘(E) a description of efforts to ensure that
hospitals and health care providers have ade-
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quate capacity and plans in place to provide
health care items and services (including mental
health services and services to meet the needs of
children and other vulnerable populations that
may include the provision of telehealth services)
in the event of a biological threat or attack; and
‘‘(F) other information the Secretary may
by regulation require.
‘‘Nothing in subparagraph (E) shall be construed
to require or recommend that States establish or
maintain stockpiles of vaccines, therapies, or other
medical supplies.
‘‘(4) USE OF FUNDS.—
‘‘(A) IN
GENERAL.—In coordination with
the activities conducted under this section, an el-
igible entity shall use amounts received under
this section to—
‘‘(i) conduct the assessment under sec-
tion 319B to achieve the capacities de-
scribed in section 319A, if the assessment
has not previously been conducted;
‘‘(ii) achieve the public health capac-
ities developed under section 319A; and
‘‘(iii) carry out the plan under para-
graph (3).
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‘‘(B) ADDITIONAL
USES.—In addition to
the activities described in subparagraph (A), an
eligible entity may use amounts received under
this subsection to—
‘‘(i) improve surveillance, detection,
and response activities to prepare for emer-
gency response activities including biologi-
cal threats or attacks, including training
personnel in these and other necessary func-
tions;
‘‘(ii) carry out activities to improve
communications and coordination efforts
within the eligible entity and between the
eligible entity and the Federal Government,
including activities to improve information
technology and communications equipment
available to health care and public health
officials for use in responding to a biologi-
cal threat or attack or other public health
emergency and including early warning
and surveillance networks that use advanced
information technology to provide early de-
tection of biological threats or attacks;
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‘‘(iii) plan for triage and transport
management in the event of a biological
threat or attack;
‘‘(iv) meet the special needs of children
and other vulnerable populations during
and after a biological threat or attack, in-
cluding the expansion of 2–1–1 call centers
or other universal hotlines, or an alternative
communication plan to assist victims and
their families in receiving timely informa-
tion;
‘‘(v) improve the ability of hospitals
and other health care facilities to provide ef-
fective health care (including mental health
care) during and after a biological threat or
attack, including the development of model
hospital preparedness plans by a hospital
accreditation organization or similar orga-
nizations; and
‘‘(vi) enhance the safety of workplaces
in the event of a biological threat or attack,
except that nothing in this clause shall be
construed to create a new, or deviate from
an existing, authority to regulate, modify,
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or otherwise effect safety and health rules
and standards.
‘‘(C) PROHIBITED USES.—An eligible entity
may not use amounts received under this sub-
section to—
‘‘(i) provide inpatient services;
‘‘(ii) make cash payments to intended
recipients of health services;
‘‘(iii) purchase or improve land or
purchase any building or other facility;
‘‘(iv) construct, repair, or alter any
building or other facility; or
‘‘(v) satisfy any requirement for the ex-
penditure of non-Federal funds as a condi-
tion for the receipt of Federal funds.
‘‘(5) AMOUNT OF GRANT.—
‘‘(A) IN GENERAL.—Except as provided in
paragraph (2), the amount awarded to a State,
the District of Columbia, or a territory under
this subsection for a fiscal year shall be an
amount that bears the same ratio to the amount
appropriated under paragraph (9) for such fiscal
year (and remaining after amounts are made
available under subparagraphs (C) and (D)) as
the total population of the State, District, or ter-
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ritory bears to the total population of the United
States.
‘‘(B) EXCEPTIONS.—
‘‘(i) MINIMUM AMOUNT WITH RESPECT
TO
STATES.—Notwithstanding 
subpara-
graph (A) and subject to the extent of
amounts made available under paragraph
(9), a State may not receive an award
under this subsection for a fiscal year in an
amount that is less than—
‘‘(I) $5,000,000 for any fiscal
year in which the total amount appro-
priated under this subsection equals or
exceeds $667,000,000; or
‘‘(II) 0.75 percent of the total
amount appropriated under this sub-
section for any fiscal year in which
such 
total 
amount 
is 
less 
than
$667,000,000.
‘‘(ii) EXTRAORDINARY NEEDS.—
‘‘(I) 
IN
GENERAL.—Notwith-
standing subparagraph (A) and subject
to the extent of amounts made avail-
able under paragraph (9), the Sec-
retary may provide additional funds to
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a State, District, or territory under
this subsection if the Secretary deter-
mines that such State, District, or ter-
ritory has extraordinary needs with re-
spect to bioterrorism preparedness.
‘‘(II) FINDING WITH RESPECT TO
THE DISTRICT OF COLUMBIA.—As a re-
sult of the concentration of entities of
national significance located within
the District of Columbia, Congress
finds that the District of Columbia has
extraordinary needs with respect to
bioterrorism preparedness, and the
Secretary shall recognize such finding
for purposes of subclause (I).
‘‘(C) RULE WITH RESPECT TO UNEXPENDED
FUNDS.—To the extent that all the funds appro-
priated under paragraph (9) for a fiscal year
and available in such fiscal year are not other-
wise paid to eligible entities because—
‘‘(i) one or more eligible entities have
not submitted an application or public
health disaster plan in accordance with
paragraphs (2) and (3) for the fiscal year;
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‘‘(ii) one or more eligible entities have
notified the Secretary that they do not in-
tend to use the full amount awarded under
this subsection; or
‘‘(iii) some eligible entity amounts are
offset or repaid;
such excess shall be provided to each of the re-
maining eligible entities in proportion to the
amount otherwise provided to such entities under
this paragraph for the fiscal year without regard
to this subparagraph.
‘‘(D) 
AVAILABILITY
OF
FUNDS.—Any
amount paid to an eligible entity for a fiscal
year under this subsection and remaining unob-
ligated at the end of such year shall remain
available for the next fiscal year to such entity
for the purposes for which it was made.
‘‘(6) INDIAN TRIBES.—
‘‘(A) IN GENERAL.—If the Secretary—
‘‘(i) receives a request from the gov-
erning body of an Indian tribe or tribal or-
ganization within any State that funds
under this subsection be provided directly
by the Secretary to such tribe or organiza-
tion; and
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‘‘(ii) determines that the members of
such tribe or tribal organization would be
better served by means of grants or agree-
ments made directly by the Secretary under
this subsection;
the Secretary shall reserve from amounts which
would otherwise be provided to such State under
this subsection for the fiscal year the amount de-
termined under subparagraph (B).
‘‘(B) AMOUNT.—The Secretary shall reserve
for the purpose of subparagraph (A) from
amounts that would otherwise be paid to such
State under paragraph (1) an amount equal to
the amount which bears the same ratio to the
amount awarded to the State for the fiscal year
involved as the population of the Indian tribe or
the individuals represented by the tribal organi-
zation bears to the total population of the State.
‘‘(C) GRANT.—The amount reserved by the
Secretary on the basis of a determination under
this paragraph shall be granted to the Indian
tribe or tribal organization serving the individ-
uals for whom such a determination has been
made.
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‘‘(D) PLAN.—In order for an Indian tribe
or tribal organization to be eligible for a grant
for a fiscal year under this paragraph, it shall
submit to the Secretary a plan for such fiscal
year which meets such criteria as the Secretary
may prescribe.
‘‘(E) DEFINITIONS.—In this paragraph, the
terms ‘Indian tribe’ and ‘tribal organization’
have the same meaning given such terms in sec-
tion 4(b) and section 4(c) of the Indian Self-De-
termination and Education Assistance Act.
‘‘(7) WITHHOLDING.—
‘‘(A) REQUIREMENTS.—
‘‘(i) 
IN
GENERAL.—The 
Secretary
shall, after adequate notice and an oppor-
tunity for a hearing conducted within the
affected eligible entity, withhold or recoup
funds from any such entity that does not
use amounts received under this subsection
in accordance with the requirements of this
subsection. The Secretary shall withhold or
recoup such funds until the Secretary finds
that the reason for the withholding or
recoupment has been removed and there is
reasonable assurance that it will not recur.
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‘‘(ii) INVESTIGATION.—The Secretary
may not institute proceedings to withhold
or recoup funds under clause (i) unless the
Secretary has conducted an investigation
concerning whether the eligible entity has
used grant or agreement amounts in accord-
ance with the requirements of this sub-
section. Investigations required by this
clause shall be conducted within the affected
entity by qualified investigators.
‘‘(iii) RESPONSE
TO
COMPLAINTS.—
The Secretary shall respond in an expedi-
tious manner to complaints of a substantial
or serious nature that an eligible entity has
failed to use funds in accordance with the
requirements of this subsection.
‘‘(iv) MINOR
FAILURES.—The Sec-
retary may not withhold or recoup funds
under clause (i) from an eligible entity for
a minor failure to comply with the require-
ments of this subsection.
‘‘(B) AVAILABILITY
OF
INFORMATION
FOR
INSPECTION.—Each eligible entity, and other en-
tity which has received funds under this section,
shall make appropriate books, documents, pa-
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pers, and records available to the Secretary or
the Comptroller General of the United States, or
any of their duly authorized representatives, for
examination, copying, or mechanical reproduc-
tion on or off the premises of the appropriate en-
tity upon a reasonable request therefore.
‘‘(C) LIMITATION ON REQUESTS FOR INFOR-
MATION.—
‘‘(i) IN GENERAL.—In conducting any
investigation in an eligible entity, the Sec-
retary or the Comptroller General of the
United States may not make a request for
any information not readily available to
such eligible entity, or an entity which has
received funds under this subsection, or
make an unreasonable request for informa-
tion to be compiled, collected, or transmitted
in any form not readily available.
‘‘(ii) JUDICIAL PROCEEDINGS.—Clause
(i) does not apply to the collection, compila-
tion, or transmittal of data in the course of
a judicial proceeding.
‘‘(8) DEFINITION.—In this subsection, the term
‘State’ means any of the several States.
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‘‘(9) AUTHORIZATION
OF
APPROPRIATIONS.—
There is authorized to be appropriated to carry out
this subsection, $667,000,000 for fiscal year 2002, and
such sums as may be necessary for fiscal year 2003,
and no funds are authorized to be appropriated for
subsequent fiscal years.’’.
(b) REAUTHORIZATION OF OTHER PROGRAMS.—Sec-
tion 319F(i) of the Public Health Service Act (42 U.S.C.
247d–6(i)) is amended to read as follows:
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated—
‘‘(1) to carry out subsection (d), $370,000,000 for
fiscal year 2002, and such sums as may be necessary
for each subsequent fiscal year through 2006; and
‘‘(2) to carry out subsections (a), (b), and (e)
through (i), such sums as may be necessary for each
of fiscal years 2002 through 2006.’’.
Subtitle B—Improving Local Pre-
paredness and Response Capa-
bilities
SEC. 311. DESIGNATED BIOTERRORISM RESPONSE MEDICAL
CENTERS.
Section 319F of the Public Health Service Act (42
U.S.C. 247d–6) is amended—
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(1) by redesignating subsections (d) through (h)
and (i), as subsections (e) through (i) and (l), respec-
tively; and
(2) by inserting after subsection (c), the fol-
lowing:
‘‘(d) DESIGNATED BIOTERRORISM RESPONSE MED-
ICAL CENTERS.—
‘‘(1) 
GRANTS.—The 
Secretary 
shall 
award
project grants to eligible entities to enable such enti-
ties, in a manner consistent with applicable provi-
sions of the Bioterrorism Preparedness and Response
Plan, to improve local and bioterrorism response
medical center preparedness.
‘‘(2) ELIGIBILITY.—To be eligible for a grant
under paragraph (1), an entity shall—
‘‘(A) be a consortium that consists of at
least one entity from each of the following
categories—
‘‘(i) a hospital including children’s
hospitals, clinic, health center, or primary
care facility;
‘‘(ii) a political subdivision of a State;
and
‘‘(iii) a department of public health;
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‘‘(B) prepare, in consultation with the Chief
Executive Officer of the State, District, or terri-
tory in which the hospital, clinic, health center,
or primary care facility is located, and submits
to the Secretary, an application at such time, in
such manner, and containing such information
as the Secretary may require;
‘‘(C) within a reasonable period of time
after receiving a grant under paragraph (1),
meet such technical guidelines as may be appli-
cable under paragraph (4); and
‘‘(D) provide assurances satisfactory to the
Secretary that such entity shall, upon the request
of the Secretary or the Chief Executive Officer of
the State, District, or territory in which the enti-
ty is located, during the emergency period, serve
the needs of the emergency area, including pro-
viding adequate health care capacity, serving as
a regional resource in the diagnosis, treatment,
or care for persons, including children and other
vulnerable populations, exposed to a biological
threat or attack, and accepting the transfer of
patients, where appropriate.
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‘‘(3) USE OF FUNDS.—An entity that receives a
grant under paragraph (1) shall use funds received
under the grant for activities that include—
‘‘(A) the training of health care profes-
sionals to enhance the ability of such personnel
to recognize the symptoms of exposure to a po-
tential biological threat or attack and to provide
treatment to those so exposed;
‘‘(B) the training of health care profes-
sionals to recognize and treat the mental health
consequences of a biological threat or attack;
‘‘(C) increasing the capacity of such entity
to provide appropriate health care for large
numbers of individuals exposed to a biological
threat or attack;
‘‘(D) the purchase of reserves of vaccines,
therapies, and other medical supplies to be used
until materials from the Strategic National
Pharmaceutical Stockpile arrive;
‘‘(E) training and planning to protect the
health and safety of personnel involved in re-
sponding to a biological threat or attack; or
‘‘(F) other activities determined appropriate
by the Secretary.
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‘‘(4) PROHIBITED USES.—An eligible entity may
not use amounts received under this subsection to—
‘‘(A) purchase or improve land or purchase
any building or other facility; or
‘‘(B) construct, repair, or alter any building
or facility.
‘‘(6) TECHNICAL
ASSISTANCE.—Not later than
180 days after the date of enactment of the Bioter-
rorism Preparedness Act of 2001, the Secretary shall
develop and publish technical guidelines relating to
equipment, training, treatment, capacity, and per-
sonnel, relevant to the status as a bioterrorism re-
sponse medical center and the Secretary may provide
technical assistance to eligible entities, including as-
sistance to address the needs of children and other
vulnerable populations.’’.
SEC. 312. DESIGNATED STATE PUBLIC EMERGENCY AN-
NOUNCEMENT PLAN.
Section 613(b) of the Robert T. Stafford Disaster Relief
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
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(3) by adding at the end the following:
‘‘(7) include a plan for providing information to
the public in a coordinated manner.’’.
SEC. 313. TRAINING FOR PEDIATRIC ISSUES SURROUNDING
BIOLOGICAL AGENTS USED IN WARFARE AND
TERRORISM.
Section 319F(f) of the Public Health Service Act (42
U.S.C. 247d–6(e)), as so redesignated by section 311, is
amended—
(1) in paragraph (1)—
(A) by inserting ‘‘(including mental health
care)’’ after ‘‘and care’’; and
(B) by striking ‘‘and’’ at the end;
(2) in paragraph (2), by striking the period and
inserting ‘‘; and’’; and
(3) by adding at the end the following:
‘‘(3) develop educational programs for health
care professionals, recognizing the special needs of
children and other vulnerable populations.’’.
SEC. 314. GENERAL ACCOUNTING OFFICE REPORT.
Section 319F(h) of the Public Health Service Act (42
U.S.C. 247d–6(g)), as so redesignated by section 311, is
amended—
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(1) by striking ‘‘Not later than 180 days after
the date of the enactment of this section, the’’ and in-
serting ‘‘The’’;
(2) in paragraph (3), by striking ‘‘and’’ at the
end;
(3) in paragraph (4), by striking the period and
inserting a semicolon; and
(4) by adding at the end the following:
‘‘(5) the activities and cost of the Civil Support
Teams of the National Guard in responding to bio-
logical threats or attacks against the civilian popu-
lation;
‘‘(6) the activities of the working group described
in subsection (a) and the efforts made by such group
to carry out the activities described in such sub-
section;
‘‘(7) the activities and cost of the 2–1–1 call cen-
ters and other universal hotlines; and
‘‘(8) the activities and cost of the development
and improvement of public health laboratory capac-
ity.’’.
SEC. 315. ADDITIONAL RESEARCH.
Section 22 of the Occupational Safety and Health Act
of 1970 (29 U.S.C. 671) is amended by adding at the end
the following:
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‘‘(h) RESEARCH RELATING TO BIOLOGICAL THREATS
OR ATTACKS IN THE WORKPLACE.—The Director shall en-
hance and expand research as deemed appropriate by the
Director on the health and safety of workers who are at
risk for biological threats or attacks in the workplace.’’.
SEC. 316. SENSE OF THE SENATE.
It is the sense of the Senate that—
(1) many excellent university-based programs
are already functioning and developing important
biodefense products and solutions throughout the
United States;
(2) accelerating the crucial work done at univer-
sity centers and laboratories will contribute signifi-
cantly to the United States capacity to defend against
any biological threat or attack;
(3) maximizing the effectiveness of, and extend-
ing the mission of, established university programs
would be one appropriate use of the additional re-
sources provided for in the Bioterrorism Preparedness
Act of 2001; and
(4) Congress recognizes the importance of exist-
ing public and private university-based research,
training, public awareness, and safety related biologi-
cal defense programs in the awarding of grants and
contracts made in accordance with this Act.
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TITLE 
IV—DEVELOPING 
NEW
COUNTERMEASURES AGAINST
BIOTERRORISM
SEC. 401. LIMITED ANTITRUST EXEMPTION.
Section 2 of the Clayton Act (15 U.S.C. 13) is amended
by adding at the end the following:
‘‘(g) LIMITED ANTITRUST EXEMPTION.—
‘‘(1) COUNTERMEASURES DEVELOPMENT MEET-
INGS.—
‘‘(A) 
COUNTERMEASURES
DEVELOPMENT
MEETINGS AND CONSULTATIONS.—The Secretary
may conduct meetings and consultations with
parties involved in the development of priority
countermeasures for the purpose of the develop-
ment, manufacture, distribution, purchase, or
sale of priority countermeasures consistent with
the purposes of this title. The Secretary shall
give notice of such meetings and consultations to
the Attorney General and the Chairperson of the
Federal Trade Commission (referred to in this
subsection as the ‘Chairperson’).
‘‘(B) MEETING AND CONSULTATION CONDI-
TIONS.—A meeting or consultation conducted
under subparagraph (A) shall—
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‘‘(i) be chaired or, in the case of a con-
sultation, facilitated by the Secretary;
‘‘(ii) be open to parties involved in the
development, 
manufacture, 
distribution,
purchase, or sale of priority counter-
measures, as determined by the Secretary;
‘‘(iii) be open to the Attorney General
and the Chairperson;
‘‘(iv) be limited to discussions involv-
ing the development, manufacture, distribu-
tion, or sale of priority countermeasures,
consistent with the purposes of this title;
and
‘‘(v) be conducted in such manner as to
ensure that national security, confidential,
and proprietary information is not dis-
closed outside the meeting or consultation.
‘‘(C) MINUTES.—The Secretary shall main-
tain minutes of meetings and consultations
under this subsection, which shall not be dis-
closed under section 552 of title 5, United States
Code.
‘‘(D) EXEMPTION.—The antitrust laws shall
not apply to meetings and consultations under
this paragraph, except that any agreement or
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conduct that results from a meeting or consulta-
tion and that does not receive an exemption pur-
suant to this subsection shall be subject to the
antitrust laws.
‘‘(2) WRITTEN
AGREEMENTS.—The Secretary
shall file a written agreement regarding covered ac-
tivities, made pursuant to meetings or consultations
conducted under paragraph (1) and that is consistent
with this paragraph, with the Attorney General and
the Chairperson for a determination of the compliance
of such agreement with antitrust laws. In addition to
the proposed agreement itself, any such filing shall
include—
‘‘(A) an explanation of the intended purpose
of the agreement;
‘‘(B) a specific statement of the substance of
the agreement;
‘‘(C) a description of the methods that will
be utilized to achieve the objectives of the agree-
ment;
‘‘(D) an explanation of the necessity of a co-
operative effort among the particular partici-
pating parties to achieve the objectives of the
agreement; and
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‘‘(E) any other relevant information deter-
mined necessary by the Secretary in consultation
with the Attorney General and the Chairperson.
‘‘(3) DETERMINATION.—The Attorney General,
in consultation with the Chairperson, shall determine
whether an agreement regarding covered activities re-
ferred to in paragraph (2) would likely—
‘‘(A) be in compliance with the antitrust
laws, and so inform the Secretary and the par-
ticipating parties; or
‘‘(B) violate the antitrust laws, in which
case, the filing shall be deemed to be a request for
an exemption from the antitrust laws, limited to
the performance of the agreement consistent with
the purposes of this title.
‘‘(4) ACTION ON REQUEST FOR EXEMPTION.—
‘‘(A) IN GENERAL.—The Attorney General,
in consultation with the Chairperson, shall
grant, deny, grant in part and deny in part, or
propose modifications to a request for exemption
from the antitrust laws under paragraph (3)
within 15 days of the receipt of such request.
‘‘(B) EXTENSION.—The Attorney General
may extend the 15-day period referred to in sub-
paragraph (A) for an additional period of not to
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exceed 10 days. Such additional period may be
further extended only by the United States dis-
trict court, upon an application by the Attorney
General after notice to the Secretary and the
parties involved.
‘‘(C) DETERMINATION.—In granting an ex-
emption under this paragraph, the Attorney
General, in consultation with the Chairperson
and the Secretary—
(i) must find—
‘‘(I) that the agreement involved
is necessary to ensure the availability
of priority countermeasures;
‘‘(II) that the exemption from the
antitrust laws would promote the pub-
lic interest; and
‘‘(III) that there is no substantial
competitive impact to areas not di-
rectly related to the purposes of the
agreement; and
‘‘(ii) may consider any other factors
determined relevant by the Attorney General
and the Chairperson.
‘‘(5) LIMITATION ON AND RENEWAL OF EXEMP-
TIONS.—An exemption granted under paragraph (4)
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shall be limited to covered activities, and shall expire
on the date that is 3 years after the date on which
the exemption becomes effective (and at 3 year inter-
vals thereafter, if renewed) unless the Attorney Gen-
eral in consultation with the Chairperson determines
that the exemption should be renewed (with modifica-
tions, as appropriate) considering the factors de-
scribed in paragraph (4).
‘‘(6) LIMITATION ON PARTIES.—The use of any
information acquired under an exempted agreement
by the parties to such an agreement for any purposes
other than those specified in the antitrust exemption
granted by the Attorney General shall be subject to the
antitrust laws and any other applicable laws.
‘‘(7) GUIDELINES.—The Attorney General and
the Chairperson may develop and issue guidelines to
implement this subsection.
‘‘(8) REPORT.—Not later than 1 year after the
date of enactment of the Bioterrorism Preparedness
Act of 2001, and annually thereafter, the Attorney
General and the Chairperson shall report to Congress
on the use and continuing need for the exemption
from the antitrust laws provided by this subsection.
‘‘(9) SUNSET.—The authority of the Attorney
General to grant or renew a limited antitrust exemp-
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tion under this subsection shall expire at the end of
the 6-year period that begins on the date of enactment
of the Bioterrorism Preparedness Act of 2001.
‘‘(h) DEFINITIONS.—In this section and title XXVIII
of the Public Health Service Act:
‘‘(1) ANTITRUST
LAWS.—The term ‘antitrust
laws’—
‘‘(A) has the meaning given such term in
subsection (a) of the first section of the Clayton
Act (15 U.S.C. 12(a)), except that such term in-
cludes the Act of June 19, 1936 (15 U.S.C. 13
et seq.) commonly known as the Robinson-Pat-
man Act), and section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the extent
such section 5 applies to unfair methods of com-
petition; and
‘‘(B) includes any State law similar to the
laws referred to in subparagraph (A).
‘‘(2) COVERED ACTIVITIES.—
‘‘(A) IN GENERAL.—Except as provided in
subparagraph (B), the term ‘covered activities’
means any group of activities or conduct, includ-
ing attempting to make, making, or performing
a contract or agreement or engaging in other
conduct, for the purpose of—
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‘‘(i) theoretical analysis, experimen-
tation, or the systematic study of phe-
nomena or observable facts necessary to the
development of priority countermeasures;
‘‘(ii) the development or testing of
basic engineering techniques necessary to
the 
development 
of 
priority 
counter-
measures;
‘‘(iii) the extension of investigative
findings or theory of a scientific or tech-
nical nature into practical application for
experimental and demonstration purposes,
including the experimental production and
testing of models, prototypes, equipment,
materials, and processes necessary to the de-
velopment of priority countermeasures;
‘‘(iv) the production, distribution, or
marketing of a product, process, or service
that is a priority countermeasures;
‘‘(v) the testing in connection with the
production of a product, process, or services
necessary to the development of priority
countermeasures;
‘‘(vi) the collection, exchange, and
analysis of research or production informa-
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tion necessary to the development of pri-
ority countermeasures; or
‘‘(vii) any combination of the purposes
described in clauses (i) through (vi);
and such term may include the establishment
and operation of facilities for the conduct of cov-
ered activities described in clauses (i) through
(vi), the conduct of such covered activities on a
protracted and proprietary basis, and the proc-
essing of applications for patents and the grant-
ing of licenses for the results of such covered ac-
tivities.
‘‘(B) EXCEPTION.—The term ‘covered ac-
tivities’ shall not include the following activities
involving 2 or more persons:
‘‘(i) Exchanging information among
competitors relating to costs, sales, profit-
ability, prices, marketing, or distribution of
any product, process, or service if such in-
formation is not reasonably necessary to
carry out the purposes of covered activities.
‘‘(ii) Entering into any agreement or
engaging in any other conduct—
‘‘(I) to restrict or require the sale,
licensing, or sharing of inventions, de-
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velopments, 
products, 
processes, 
or
services not developed through, pro-
duced by, or distributed or sold
through such covered activities; or
‘‘(II) to restrict or require partici-
pation by any person who is a party
to such covered activities in other re-
search and development activities, that
is not reasonably necessary to prevent
the misappropriation of proprietary
information contributed by any person
who is a party to such covered activi-
ties or of the results of such covered ac-
tivities.
‘‘(iii) Entering into any agreement or
engaging in any other conduct allocating a
market with a competitor that is not ex-
pressly exempted from the antitrust laws by
a determination under subsection (i)(4).
‘‘(iv) Exchanging information among
competitors relating to production (other
than production by such covered activities)
of a product, process, or service if such in-
formation is not reasonably necessary to
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carry out the purpose of such covered activi-
ties.
‘‘(v) Entering into any agreement or
engaging in any other conduct restricting,
requiring, or otherwise involving the pro-
duction of a product, process, or service that
is not so expressly exempted from the anti-
trust laws by a determination under sub-
section (i)(4).
‘‘(vi) Except as otherwise provided in
this subsection, entering into any agreement
or engaging in any other conduct to restrict
or require participation by any person who
is a party to such activities, in any unilat-
eral or joint activity that is not reasonably
necessary to carry out the purpose of such
covered activities.
‘‘(3) DEVELOPMENT.—The term ‘development’
includes the identification of suitable compounds or
biological materials, the conduct of preclinical and
clinical studies, the preparation of an application for
marketing approval, and any other actions related to
preparation of a countermeasure.
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‘‘(4) PERSON.—The term ‘person’ has the mean-
ing given such term in subsection (a) of the first sec-
tion of the Clayton Act (15 U.S.C. 12(a)).
‘‘(5) PRIORITY
COUNTERMEASURE.—The term
‘priority countermeasure’ means a countermeasure,
including a drug, medical device, biological product,
or diagnostic test to treat, identify, or prevent infec-
tion by a biological agent or toxin on the list devel-
oped under section 351A(a)(1) and prioritized under
subsection (a)(1).’’.
SEC. 402. DEVELOPING NEW COUNTERMEASURES AGAINST
BIOTERRORISM.
Title XXVIII of the Public Health Service Act, as
added by section 101 and amended by section 201, is further
amended by adding at the end the following:
‘‘Subtitle B—Developing New Coun-
termeasures 
Against 
Bioter-
rorism
‘‘SEC. 2841. SMALLPOX VACCINE AND OTHER VACCINE DE-
VELOPMENT.
‘‘(a) IN GENERAL.—The Secretary shall award con-
tracts, enter into cooperative agreements, or carry out such
other activities as may reasonably be required in order to
ensure that the stockpile described in section 2812 shall in-
clude the number of doses of vaccine against smallpox and
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other such vaccines determined by the Secretary to be suffi-
cient to meet the needs of the population of the United
States.
‘‘(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to limit the private distribution,
purchase, or sale of vaccines from sources other than the
stockpile described in subsection (a).
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section,
$509,000,000 for fiscal year 2002, and such sums as may
be necessary for each of fiscal years 2003 through 2006.
‘‘SEC. 2842. CONTRACT AUTHORITY FOR PRIORITY COUN-
TERMEASURES.
‘‘(a) IN GENERAL.—The Secretary shall, to the extent
the Secretary determines necessary to achieve the purposes
of this title, enter into long-term contracts and comparable
grants or cooperative agreements, for the purpose of—
‘‘(1) ensuring the development of priority coun-
termeasures that are necessary to prepare for a bioter-
rorist attack or other significant disease emergency;
‘‘(2) securing the manufacture, distribution, and
adequate supply of such countermeasures, including
through the development of novel production methods
for such countermeasures;
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‘‘(3) maintaining the Strategic National Phar-
maceutical Stockpile under section 2812; and
‘‘(4) carrying out such other activities deter-
mined appropriate by the Secretary to achieve the
purposes of this title.
‘‘(b) TERMS OF CONTRACTS.—Notwithstanding any
other provision of law, the Secretary may enter into a con-
tract or cooperative agreement under subsection (a) prior
to the development, approval, or clearance of the counter-
measure that is the subject of the contract. The contract or
cooperative agreement may provide for its termination for
the convenience of the Federal Government if the contractor
does not develop the countermeasure involved. Such a con-
tract or cooperative agreement may—
‘‘(1) involve one or more aspects of the develop-
ment, manufacture, purchase, or distribution of one
or more uses of one or more countermeasures; and
‘‘(2) set forth guaranteed minimum quantities of
products and negotiated unit prices.
‘‘SEC. 2843. SECURITY FOR COUNTERMEASURE DEVELOP-
MENT AND PRODUCTION.
‘‘(a) IN GENERAL.—The Secretary, in consultation
with the Attorney General and the Secretary of Defense,
may provide technical or other assistance, to provide secu-
rity to persons or facilities that conduct development, pro-
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duction, distribution, or storage of priority counter-
measures.
‘‘(b) BEST PRACTICES.—The Secretary shall develop
guidelines and best practices to enable entities eligible to
receive assistance under this section to secure their facilities
against potential terrorist attack.’’.
SEC. 403. SEQUENCING OF PRIORITY PATHOGENS.
Section 319F(g) of the Public Health Service Act (42
U.S.C. 247d–6(f)), as so redesignated by section 311, is
amended—
(1) in paragraph (3), by striking ‘‘and’’ at the
end;
(2) by redesignating paragraph (4) as para-
graph (5); and
(3) by inserting after paragraph (3), the fol-
lowing:
‘‘(4) the sequencing of the genomes of priority
pathogens as determined appropriate by the Director
of the National Institutes of Health, in consultation
with the working group established in subsection (a);
and’’.
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SEC. 404. ACCELERATED COUNTERMEASURE RESEARCH
AND DEVELOPMENT.
Section 319F(g) of the Public Health Service Act (42
U.S.C. 247d–6(f)), as so redesignated by section 311 and
amended by section 403, is further amended—
(1) by redesignating paragraphs (1) through (5),
as subparagraphs (A) through (E), respectively and
indenting appropriately;
(2) by striking ‘‘The Secretary’’ and inserting
the following:
‘‘(1) IN GENERAL.—The Secretary’’; and
(3) by adding at the end the following:
‘‘(2) 
ACCELERATED
COUNTERMEASURE
RE-
SEARCH AND DEVELOPMENT.—
‘‘(A) IN
GENERAL.—The Secretary shall
conduct, and award grants, contracts, or cooper-
ative agreements for, research, investigations, ex-
periments, demonstrations, and studies in the
health sciences relating to—
‘‘(i) the epidemiology and pathogenesis
of biological agents or toxins of potential
use in a bioterrorist attack;
‘‘(ii) the development of new vaccines
and therapeutics for use against biological
agents or toxins of potential use in a bioter-
rorist attack;
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‘‘(iii) the development of diagnostic
tests to detect biological agents or toxins of
potential use in a bioterrorist attack; and
‘‘(iv) other relevant areas of research;
with consideration given to the needs of children
and other vulnerable populations.
‘‘(B) PRIORITY.—The Secretary shall give
priority under this paragraph to the funding of
research and other studies related to priority
countermeasures.’’.
SEC. 405. 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 Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 356) or as
a device granted priority review pursuant to section
515(d)(5) of such Act (21 U.S.C. 366e(d)(5)). Such a des-
ignation may be made prior to the submission of—
(1) a request for designation by the sponsor or
applicant; 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.
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Nothing in this subsection shall be construed to prohibit a
sponsor or applicant from declining such a designation.
(b) USE OF ANIMAL TRIALS.—A drug for which ap-
proval is sought under section 505(d) of the Federal Food,
Drug, and Cosmetic Act or section 351 of the Public Health
Service Act on the basis of evidence of effectiveness that is
derived from animal studies under section 406 may be des-
ignated as a fast track product for purposes of this section.
(c) PRIORITY REVIEW.—
(1) IN
GENERAL.—A priority countermeasure
that is a drug or biological product shall be subject
to the performance goals established by the Commis-
sioner of Food and Drugs for priority drugs or bio-
logical products.
(2) DEFINITION.—In this subsection the term
‘‘priority drugs or biological products’’ means a drug
or biological product that is the subject of a drug ap-
plication referred to in section 101(4) of the Food and
Drug Administration Modernization Act of 1997.
SEC. 406. USE OF ANIMAL TRIALS IN THE APPROVAL OF
PRIORITY COUNTERMEASURES.
Not later than 30 days after the date of enactment of
this Act, the Secretary of Health and Human Services shall
issue a final rule for the proposal entitled ‘‘New Drug and
Biological Drug Products; Evidence Needed to Demonstrate
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Efficacy of New Drugs for Use Against Lethal or Perma-
nently Disabling Toxic Substances When Efficacy Studies
in Humans Ethically Cannot be Conducted’’ as published
in the Federal Register on October 5, 1999 (64 Fed. Reg.).
SEC. 407. MISCELLANEOUS PROVISIONS.
Title XXVIII of the Public Health Service Act, as
added by section 101 and amended by section 403, is further
amended by adding at the end the following:
‘‘Subtitle C—Miscellaneous
Provisions
‘‘SEC. 2851. SUPPLEMENT NOT SUPPLANT.
‘‘A State or local government, or other entity to which
a grant, contract, or cooperative agreement is awarded
under this title, may not use amounts received under the
grant, contract, or cooperative agreement to supplant ex-
penditures by the entity for activities provided for under
this title, but shall use such amounts only to supplement
such expenditures at a level at least equal to the level of
such expenditures for fiscal year 2001 (excluding those ad-
ditional, extraordinary expenditures that may have been
made after September 10, 2001).’’.
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TITLE 
V—PROTECTING 
THE
SAFETY AND SECURITY OF
THE FOOD SUPPLY
Subtitle A—General Provisions to
Expand and Upgrade Security
SEC. 511. FOOD SAFETY AND SECURITY STRATEGY.
(a) IN GENERAL.—The President’s Council on Food
Safety (as established by Executive Order 13100), the Sec-
retary of Commerce, and the Secretary of Transportation,
shall, in consultation with the food industry and consumer
and producer groups, and the States, develop a crisis com-
munications and education strategy with respect to bioter-
rorist threats to the food supply. Such strategy shall address
threat assessments, response and notification procedures,
and risks communications to the public.
(b) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated, $500,000 for fiscal year
2002, and such sums as may be necessary in each subse-
quent fiscal year to implement the strategy developed under
subsection (a) in cooperation with the Secretary of Agri-
culture, the Secretary of Health and Human Services, and
the Administrator of the Environmental Protection Agency.
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SEC. 512. EXPANSION OF ANIMAL AND PLANT HEALTH IN-
SPECTION SERVICE ACTIVITIES.
(a) IN GENERAL.—The Secretary of Agriculture (re-
ferred to in this section as the ‘‘Secretary’’) shall enhance
and expand the capacity of the Animal and Plant Health
Inspection Service through the conduct of activities to—
(1) increase the inspection capacity of the Serv-
ice at international points of origin;
(2) improve surveillance at ports of entry and
customs;
(3) enhance methods of protecting against the in-
troduction of plant and animal disease organisms by
terrorists;
(4) adopt new strategies and technologies for
dealing with intentional outbreaks of plant and ani-
mal disease arising from acts of terrorism or from
unintentional introduction, including—
(A) establishing cooperative agreements
among Veterinary Services of the Animal and
Plant Health Inspection Service, State animal
health commissions and regulatory agencies for
livestock and poultry health, and private veteri-
nary practitioners to enhance the preparedness
and ability of Veterinary Services and the com-
missions and agencies to respond to outbreaks of
such animal diseases; and
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(B) strengthening planning and coordina-
tion with State and local agencies, including—
(i) State animal health commissions
and regulatory agencies for livestock and
poultry health; and
(ii) State agriculture departments; and
(5) otherwise expand the capacity of the Service
to protect against the threat of bioterrorism.
(b) HIGH-TECH AGRICULTURE EARLY WARNING AND
EMERGENCY RESPONSE SYSTEM.—
(1) IN GENERAL.—To provide the agricultural
system of the United States with a new, enhanced
level of protection and biosecurity that does not exist
on the date of enactment of this Act, the Secretary of
Agriculture, in coordination with the Secretary of
Health and Human Services, shall implement a fully
secure surveillance and response system that utilizes,
or is capable of utilizing, field test devices capable of
detecting biological threats to animals and plants and
that electronically integrates the devices and the tests
on a real-time basis into a comprehensive surveil-
lance, incident management, and emergency response
system.
(2) EXPANSION OF SYSTEM.—The Secretary shall
expand the system implemented under paragraph (1)
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as soon as practicable to include other Federal agen-
cies and the States where appropriate and necessary
to enhance the protection of the food and agriculture
system of the United States. To facilitate the expan-
sion of the system, the Secretary shall award grants
to States.
(c) AUTOMATED RECORDKEEPING SYSTEM.—The Ad-
ministrator of the Animal and Plant Health Inspection
Service shall implement a central automated recordkeeping
system to provide for the reliable tracking of the status of
animal and plant shipments, including those shipments on
hold at ports of entry and customs. The Secretary shall en-
sure that such a system shall be fully accessible to or fully
integrated with the Food Safety Inspection Service.
(d) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section,
$30,000,000 for fiscal year 2002, and such sums as may
be necessary for each subsequent fiscal year.
SEC. 513. EXPANSION OF FOOD SAFETY INSPECTION SERV-
ICE ACTIVITIES.
(a) IN GENERAL.—The Secretary of Agriculture shall
enhance and expand the capacity of the Food Safety Inspec-
tion Service through the conduct of activities to—
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(1) enhance the ability of the Service to inspect
and ensure the safety and wholesomeness of meat and
poultry products;
(2) improve the capacity of the Service to inspect
international meat and meat products, poultry and
poultry products, and egg products at points of origin
and at ports of entry;
(3) strengthen the ability of the Service to col-
laborate with relevant agencies within the Depart-
ment of Agriculture and with other entities in the
Federal Government, the States, and Indian tribes
through the sharing of information and technology;
and
(4) otherwise expand the capacity of the Service
to protect against the threat of bioterrorism.
(b) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section,
$15,000,000 for fiscal year 2002, and such sums as may
be necessary for each subsequent fiscal year.
SEC. 514. EXPANSION OF FOOD AND DRUG ADMINISTRA-
TION ACTIVITIES.
(a) IN GENERAL.—The Secretary of Health and
Human Services shall expand the capacity of the Food and
Drug Administration to—
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(1) increase inspections to ensure the safety of
the food supply consistent with the amendments made
by subtitle B; and
(2) improve linkages between the Agency and
other regulatory agencies of the Federal Government,
the States, and Indian tribes with shared responsibil-
ities.
(b) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section,
$59,000,000 for fiscal year 2002, and such sums as may
be necessary for each subsequent fiscal year.
SEC. 515. BIOSECURITY UPGRADES AT THE DEPARTMENT
OF AGRICULTURE.
There is authorized to be appropriated for fiscal year
2002, $180,000,000 to enable the Agricultural Research
Service to conduct building upgrades to modernize existing
facilities, of which (1) $100,000,000 is allocated for renova-
tion, updating, and expansion of the Biosafety Level 3 lab-
oratory and animal research facilities at the Plum Island
Animal Disease Center (Greenport, New York), and of
which (2) $80,000,000 is allocated for the Agricultural Re-
search Service/Animal and Plant Health Inspection Service
facility in Ames, Iowa. There is authorized to be appro-
priated such sums as may be necessary in fiscal years 2003
through 2006 for (1), (2) and the planning and design of
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an Agricultural Research Service biocontainment labora-
tory for poultry research in Athens, Georgia, and the plan-
ning, updating, and renovation of the Arthropod-Borne
Animal Disease Laboratory in Laramie, Wyoming.
SEC. 516. BIOSECURITY UPGRADES AT THE DEPARTMENT
OF HEALTH AND HUMAN SERVICES.
The Secretary of Health and Human Services shall
take such actions as may be necessary to secure existing
facilities of the Department of Health and Human Services
where potential animal and plant pathogens are housed or
researched.
SEC. 517. AGRICULTURAL BIOSECURITY.
(a) LAND GRANT ASSESSMENTS.—
(1) IN GENERAL.—The Secretary of Agriculture
(referred to in this section as the ‘‘Secretary’’) shall
establish minimum security standards and award
grants to land grant universities to conduct security
needs assessments and to plan for improvement of—
(A) the security of all facilities where haz-
ardous biological agents and toxins are stored or
used for agricultural research purposes; and
(B) communication networks that transmit
information about hazardous biological agents
and toxins.
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(2) AVAILABILITY
OF
STANDARDS.—Not later
than 45 days after the establishment of security
standards under paragraph (1), the Secretary shall
make such standards available to land grant univer-
sities.
(3) GRANTS.—Not later than 45 days after the
date of enactment of this Act, the Secretary shall
award grants, not to exceed $50,000 each, to land
grant universities to enable such universities to con-
duct a security needs assessment and plan activities
to improve security. Such an assessment shall be com-
pleted not later than 45 days after the date on which
such grant funds are received.
(b) NATIONAL HAZARDOUS AGENT INVENTORY.—The
Secretary shall carry out activities necessary to develop a
national inventory of hazardous biological agents and tox-
ins contained in agricultural research facilities. Such ac-
tivities shall include developing and distributing a model
inventory procedure, developing secure means of transmit-
ting inventory information, and conducting annual inven-
tory activities. The inventory shall be developed in coordi-
nation with, or as a component of, similar systems in exist-
ence on the date of enactment of this Act.
(c) SCREENING PROTOCOL.—The Secretary shall es-
tablish a national protocol for the screening of individuals
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who require access to agricultural research facilities in a
manner that provides for the protection of personal privacy.
(d) INDUSTRY-ON-FARM EDUCATION.—
(1) IN GENERAL.—The Secretary shall develop
and implement a program to provide education relat-
ing to farms, livestock confinement operations, and
livestock auction biosecurity to prevent the intentional
or accidental introduction of a foreign animal disease
and to attempt to discover the introduction of such a
disease before it can spread into an outbreak. Biosecu-
rity for livestock includes animal quarantine proce-
dures, blood testing of new arrivals, farm locations,
control of human movement onto farms and holding
facilities, control of vermin, and movement of vehicles
onto farms.
(2) QUARANTINE AND TESTING.—The Secretary
shall develop and disseminate through educational
programs animal quarantine and testing guidelines
to enable farmers and producers to better monitor
new arrivals. Any educational seminars and training
carried out by the Secretary under this paragraph
shall emphasize the economic benefits of biosecurity
and the profound negative impact of an outbreak.
(3) CROP GUIDELINES.—The Secretary may de-
velop guidelines and educational materials relating to
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biosecurity issues to be distributed to local crop pro-
ducers and facilities that handle, process, or transport
crops.
(e) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section,
$20,000,000 for fiscal year 2002, and such sums as may
be necessary for each subsequent fiscal year, of which not
less than $5,000,000 shall be made available in fiscal year
2002 for activities under subsection (a).
SEC. 518. BIOSECURITY OF FOOD MANUFACTURING, PROC-
ESSING, AND DISTRIBUTION.
(a) IN GENERAL.—The Secretary of Health and
Human Services (referred to in this section as the ‘‘Sec-
retary’’), in consultation with the Attorney General, may
award grants, contracts, or cooperative agreements to en-
able food manufacturers, food processors, food distributors,
and other entities regulated by the Secretary to ensure the
safety of food through the development and implementation
of educational programs to ensure the security of their fa-
cilities and modes of transportation against potential bio-
terrorist attack.
(b) BEST PRACTICES.—The Secretary may develop
best practices to enable entities eligible for funding under
this section to secure their facilities and modes of transpor-
tation against potential bioterrorist attacks.
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(c) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section,
$500,000 in fiscal year 2002, and such sums as may be
necessary for each fiscal year thereafter.
Subtitle B—Protection of the Food
Supply
SEC. 531. ADMINISTRATIVE DETENTION.
(a) EXPANDED AUTHORITY.—Section 304 of the Fed-
eral Food, Drug and Cosmetic Act (21 U.S.C. 334) is
amended by adding at the end the following:
‘‘(h) ADMINISTRATIVE DETENTION OF FOODS.—
‘‘(1) AUTHORITY.—Any officer or qualified em-
ployee of the Food and Drug Administration may
order the detention, in accordance with this sub-
section, of any article of food that is found during an
inspection, examination, or investigation under this
Act conducted by such officer or qualified employee,
if the officer or qualified employee has credible evi-
dence or information indicating that the article is in
violation of this Act and presents a threat of serious
adverse health consequences or death to humans or
animals.
‘‘(2) PERIOD OF DETENTION; APPROVAL BY SEC-
RETARY OR SECRETARY’S DESIGNEE.—
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‘‘(A) DURATION.—An article of food may be
detained under this subsection for a reasonable
period, not to exceed 20 days, unless a greater
period of time, not to exceed 30 days, is nec-
essary to enable the Secretary to institute an ac-
tion under subsection (a) or section 302.
‘‘(B) SECRETARY’S
APPROVAL.—Before an
article of food may be ordered detained under
this subsection, the Secretary or an officer or
qualified employee designated by the Secretary
must approve such order, after determining that
the article presents a threat of serious adverse
health consequences or death to humans or ani-
mals.
‘‘(3) SECURITY OF DETAINED ARTICLE.—A de-
tention order under this subsection with respect to an
article of food may require that the article be labeled
or marked as detained, and may require that the arti-
cle be removed to a secure facility. An article subject
to a detention order under this subsection shall not be
moved by any person from the place at which it is
ordered detained until released by the Secretary, or
the expiration of the detention period applicable to
such order, whichever occurs first.
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‘‘(4) APPEAL OF DETENTION ORDER.—Any per-
son who would be entitled to claim a detained article
if it were seized under subsection (a) may appeal to
the Secretary the detention order under this sub-
section. Within 15 days after such an appeal is filed,
the Secretary, after affording opportunity for an in-
formal hearing, shall by order confirm the detention
order or revoke it.
‘‘(5) PERISHABLE FOODS.—The Secretary shall
provide in regulation or in guidance for procedures
for instituting and appealing on an expedited basis
administrative detention of perishable foods.’’.
(b) PROHIBITED ACT.—Section 301 of the Federal
Food, Drug and Cosmetic Act (21 U.S.C. 331) is amended
by adding at the end the following new subsection:
‘‘(bb) The movement of an article of food in vio-
lation of an order under section 304(h), or the re-
moval or alteration of any mark or label required by
the order in order to identify the article as detained.’’.
SEC. 532. DEBARMENT FOR REPEATED OR SERIOUS FOOD
IMPORT VIOLATIONS.
(a) DEBARMENT AUTHORITY.—
(1) PERMISSIVE DEBARMENT.—Section 306(b)(1)
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 335a(b)(1)) is amended—
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(A) by striking the period at the end of sub-
paragraph (B) and inserting ‘‘; or’’; and
(B) by adding at the end the following:
‘‘(C) a person from importing a food or of-
fering a food for import into the United States
if—
‘‘(i) the person has been convicted of a
felony for conduct relating to the importa-
tion into the United States of any food; or
‘‘(ii) the person has engaged in a pat-
tern of importing or offering for import
adulterated food that presents a threat of se-
rious adverse health consequences or death
to humans or animals.’’.
(2) 
CONFORMING
AMENDMENT.—Section
306(b)(2) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 335a(b)(2)) is amended—
(A) in the paragraph heading, by inserting
‘‘RELATING TO DRUG APPLICATIONS’’ after ‘‘DE-
BARMENT’’; and
(B) in the matter preceding subparagraph
(A), by striking ‘‘paragraph (1)’’ and inserting
‘‘subparagraphs (A) and (B) of paragraph (1)’’.
(3) 
DEBARMENT
PERIOD.—Section
306(c)(2)(A)(iii) of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 335a(c)(2)(A)(iii)) is amended
by striking ‘‘subsection (b)(2)’’ and inserting ‘‘sub-
section (b)(1)(C) or (b)(2)’’.
(4) 
TERMINATION
OF
DEBARMENT.—Section
306(d)(3) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 335a(d)(3)) is amended—
(A) in subparagraph (A)(i), by striking ‘‘or
(b)(2)(A)’’ and inserting ‘‘, or (b)(2)(A), or
(b)(1)(C)’’;
(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 (b)(1)(C)’’ after
‘‘(b)(2)(B)’’.
(5) EFFECTIVE DATES.—Section 306(l)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
335a(l)(2)) is amended—
(A) in the first sentence, by inserting ‘‘and
subsection 
(b)(1)(C)’’ 
after 
‘‘subsection
(b)(2)(B)’’; and
(B) in the second sentence, by striking ‘‘and
subsections (f) and (g) of this section’’ and in-
serting ‘‘subsections (f) and (g), and subsection
(b)(1)(C)’’.
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(b) CONFORMING AMENDMENT.—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 by, with the assistance of,
or at the direction of, a person debarred under section
306(b)(1)(C).’’.
SEC. 533. 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 amended
by adding at the end the following:
‘‘SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.
‘‘(a) IN GENERAL.—If the Secretary has reason to be-
lieve that an article of food is adulterated or misbranded
under this Act and presents a threat of serious adverse
health consequences or death to humans or animals, each
person (excluding restaurants and farms) that manufac-
tures, processes, packs, distributes, receives, holds, or im-
ports such food 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 with-
in reasonable limits and in a reasonable manner, to have
access to and to copy all records relating to such food that
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may assist the Secretary to determine the cause and scope
of the violation. This requirement applies to all records re-
lating to such manufacture, processing, packing, distribu-
tion, receipt, holding, or importation of such food main-
tained by or on behalf of such person in any format (includ-
ing paper and electronic formats) and at any location.
‘‘(b) REGULATIONS CONCERNING RECORDKEEPING.—
The Secretary shall promulgate regulations regarding the
maintenance and retention of records for inspection for not
longer than 2 years by persons (excluding restaurants and
farms) that manufacture, process, pack, transport, dis-
tribute, receive, hold, or import food, as may be needed to
allow the Secretary—
‘‘(1) to promptly trace the source and chain of
distribution of food and its packaging to address
threats of serious adverse health consequences or death
to humans or animals; or
‘‘(2) to determine whether food manufactured,
processed, packed, or held by the person may be adul-
terated or misbranded to the extent that it presents a
threat of serious adverse health consequences or death
to humans or animals under this Act.
The Secretary may impose reduced requirements under such
regulations for small businesses with 50 or fewer employees.
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‘‘(c) LIMITATIONS.—Nothing in this section shall be
construed—
‘‘(1) to limit the authority of the Secretary to in-
spect records or to require maintenance of records
under any other provision of or regulations issued
under this Act;
‘‘(2) to authorize the Secretary to impose any re-
quirements 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 Inspec-
tion 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 extend to recipes for food, financial data,
sales data other than shipment data, pricing data,
personnel data, or research data; or
‘‘(4) to alter, amend, or affect in any way the
disclosure or nondisclosure under section 552 of title
5, United States Code, of information copied or col-
lected under this section, or its treatment under sec-
tion 1905 of title 18, United States Code.’’.
(b) FACTORY INSPECTION.—Section 704(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is
amended—
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(1) in paragraph (1), by adding after the first
sentence the following: ‘‘In the case of any person (ex-
cluding restaurants and farms) that manufactures,
processes, packs, transports, distributes, receives,
holds, or imports foods, the inspection shall extend to
all records and other information described in section
414(a), or required to be maintained pursuant to sec-
tion 414(b).’’; and
(2) in paragraph (2), in the matter preceding
subparagraph (A), by striking ‘‘second sentence’’ and
inserting ‘‘third sentence’’.
(c) PROHIBITED ACT.—Section 301 of the Federal
Food, Drug and Cosmetic Act (21 U.S.C. 331) is
amended—
(1) in subsection (e)—
(A) by striking ‘‘by section 412, 504, or
703’’ and inserting ‘‘by section 412, 414, 504,
703, or 704(a)’’; and
(B) by striking ‘‘under section 412’’ and in-
serting ‘‘under section 412, 414(b)’’; and
(2) in section (j), by inserting ‘‘414,’’ after
‘‘412,’’.
(d) EXPEDITED RULEMAKING.—Not later than 18
months after the date of enactment of this Act, the Secretary
shall promulgate proposed and final regulations estab-
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lishing 
recordkeeping 
requirements 
under 
subsection
414(b)(1) of the Federal Food, Drug, and Cosmetic Act.
SEC. 534. REGISTRATION OF FOOD MANUFACTURING, PROC-
ESSING, AND HANDLING FACILITIES.
(a) IN GENERAL.—Chapter IV of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.), as amended
by section 533, is further amended by adding at the end
the following:
‘‘SEC. 415. REGISTRATION OF FOOD MANUFACTURING,
PROCESSING, AND HANDLING FACILITIES.
‘‘(a) REGISTRATION.—
‘‘(1) IN
GENERAL.—Any facility engaged in
manufacturing, processing, or handling food for con-
sumption 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-
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istration under paragraph (1) to the Secretary con-
taining information necessary to notify the Secretary
of the name 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 category
(as identified under section 170.3 of title 21, Code of
Federal Regulations) of any food manufactured, proc-
essed, or handled at such facility. The registrant shall
notify the Secretary in a timely manner of changes
to such information.
‘‘(3) PROCEDURE.—Upon receipt of a completed
registration described in paragraph (1), the Secretary
shall notify the registrant of the receipt of such reg-
istration 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 subsection
shall not be subject to the disclosure requirements of
section 552 of title 5, United States Code.
‘‘(b) EXEMPTION AUTHORITY.—The Secretary may by
regulation exempt types of retail establishments or farms
from the requirements of subsection (a) if the Secretary de-
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termines that the registration of such facilities is not needed
for effective enforcement of chapter IV and any regulations
issued under such chapter.
‘‘(c) FACILITY.—In this section, the term ‘facility’ in-
cludes any factory, warehouse, or establishment (including
a factory, warehouse, or establishment of an importer), that
manufactures, handles, or processes food. Such term does
not include restaurants.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to authorize the Secretary to require
an application, review, or licensing process.’’.
(b) MISBRANDED FOODS.—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 a food from a facility for which registration
has not been submitted to the Secretary under section
415(a).’’.
(c) EFFECTIVE DATE.—The amendment made by sub-
section (b) shall take effect 180 days after the date of enact-
ment of this Act.
SEC. 535. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.
(a) PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.—
Section 801 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381) is amended by adding at the end the fol-
lowing:
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‘‘(j) PRIOR
NOTICE
OF
IMPORTED
FOOD
SHIP-
MENTS.—
‘‘(1) IN GENERAL.—At least 4 hours before a food
is imported or offered for importation into the United
States, the producer, manufacturer, or shipper of the
food shall provide documentation to the Secretary of
the Treasury and the Secretary of Health and
Human Services that—
‘‘(A) identifies—
‘‘(i) the food;
‘‘(ii) the countries of origin of the food;
and
‘‘(iii) the quantity to be imported; and
‘‘(B) includes such other information as the
Secretary of Health and Human Services may
require by regulation.
‘‘(2) REFUSAL OF ADMISSION.—If documentation
is not provided as required by paragraph (1) at least
4 hours before the food is imported or offered for im-
portation, the food may be refused admission.
‘‘(3) LIMITATION.—Nothing in this subsection
shall be construed to authorize the Secretary to im-
pose 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
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Meat Inspection Act (21 U.S.C. 601 et seq.), the Poul-
try Products Inspection Act (21 U.S.C. 451 et seq.),
or the Egg Products Inspection Act (21 U.S.C. 1031
et seq.).’’.
(b) PROHIBITION
OF KNOWINGLY MAKING FALSE
STATEMENTS.—Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by section
531(b), is further amended by inserting after subsection (bb)
the following:
‘‘(cc) Knowingly making a false statement in docu-
mentation required under section 801(j).’’.
SEC. 536. AUTHORITY TO MARK REFUSED ARTICLES.
(a) MISBRANDED FOODS.—Section 403 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 343), as amended
by section 534(b), is further amended by adding at the end
the following:
‘‘(u) If—
‘‘(1) it has been refused admission under section
801(a);
‘‘(2) it has not been required to be destroyed
under section 801(a);
‘‘(3) the packaging of it does not bear a label or
labeling described in section 801(a); and
‘‘(4) it presents a threat of serious adverse health
consequences or death to humans or animals.’’.
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(b) REQUIREMENT.—Section 801(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amend-
ed by adding at the end the following: ‘‘The Secretary of
Health and Human Services may require the owner or con-
signee of a food that has been refused admission under this
section, and has not been required to be destroyed, to affix
to the packaging of the food a label or labeling that—
‘‘(1) clearly and conspicuously bears the state-
ment: ‘United States: Refused Entry’;
‘‘(2) is affixed to the packaging until the food is
brought into compliance with this Act; and
‘‘(3) has been provided at the expense of the
owner or consignee of the food.’’.
(c) RULE OF CONSTRUCTION.—Nothing in this section
shall be construed 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 under
any other provision of law.
SEC. 537. AUTHORITY TO COMMISSION OTHER FEDERAL OF-
FICIALS TO CONDUCT INSPECTIONS.
Section 702(a) of the Federal Food, Drug and Cosmetic
Act (21 U.S.C. 372(a)) is amended in the first sentence—
(1) by inserting ‘‘qualified’’ before ‘‘employees’’;
and
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(2) by inserting ‘‘or of other Federal Depart-
ments or agencies, notwithstanding any other provi-
sion of law restricting the use of a Department’s or
agency’s officers, employees, or funds,’’ after ‘‘officers
and qualified employees of the Department’’.
SEC. 538. PROHIBITION AGAINST PORT SHOPPING.
Section 402 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 342), as amended by section 532(b), is fur-
ther amended by adding at the end the following:
‘‘(i) If it is an article of food imported or offered for
import into the United States and the article of food has
previously 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 complies with the applicable requirements
of this Act, as determined by the Secretary.’’.
SEC. 539. GRANTS TO STATES FOR INSPECTIONS.
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:
‘‘SEC. 910. GRANTS TO STATES FOR INSPECTIONS.
‘‘(a) IN GENERAL.—The Secretary is authorized to
make grants to States, territories, and Federally recognized
Indian tribes that undertake examinations, inspections,
and investigations, and related activities under section 702.
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The funds provided under such grants shall only be avail-
able for the costs of conducting such examinations, inspec-
tions, investigations, and related activities.
‘‘(b) AUTHORIZATION
OF APPROPRIATIONS.—There
are authorized to be appropriated $10,000,000 for fiscal
year 2002, and such sums as may be necessary to carry
out this section for each subsequent fiscal year.’’.
SEC. 540. RULE OF CONSTRUCTION.
Nothing in this title, or an amendment made by this
title, shall be construed to—
(1) provide the Food and Drug Administration
with additional authority related to the regulation of
meat, poultry, and egg products; or
(2) limit the authority of the Secretary of Agri-
culture with respect to such products.
Subtitle C—Research and Training
to Enhance Food Safety and Se-
curity
SEC. 541. SURVEILLANCE AND INFORMATION GRANTS AND
AUTHORITIES.
Part B of title III of the Public Health Service Act
(42 U.S.C. 243 et seq.) is amended by inserting after section
317P the following:
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‘‘SEC. 317Q. FOOD SAFETY GRANTS.
‘‘(a) IN GENERAL.—The Secretary may award food
safety grants to States to expand the number of States par-
ticipating in Pulsenet, the Foodborne Diseases Active Sur-
veillance Network, and other networks to enhance Federal,
State, and local food safety efforts.
‘‘(b) USE OF FUNDS.—Funds awarded under this sec-
tion shall be used by States to assist such States in meeting
the costs of establishing and maintaining the food safety
surveillance, technical and laboratory capacity needed to
participate in Pulsenet, Foodborne Diseases Active Surveil-
lance Network, and other networks to enhance Federal,
State, and local food safety efforts.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section,
$19,500,000 for fiscal year 2002, and such sums as may
be necessary for each of fiscal years 2003 through 2006.
‘‘SEC. 317R. SURVEILLANCE OF ANIMAL AND HUMAN
HEALTH.
‘‘The Secretary, through the Commissioner of the Food
and Drug Administration and the Director of the Centers
for Disease Control and Prevention, and the Secretary of
Agriculture shall develop and implement a plan for coordi-
nating the surveillance for zoonotic disease and human dis-
ease.’’.
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SEC. 542. AGRICULTURAL BIOTERRORISM RESEARCH AND
DEVELOPMENT.
(a) IN GENERAL.—The Secretary of Agriculture, to the
maximum extent practicable, shall utilize existing authori-
ties to expand Agricultural Research Service, and Coopera-
tive State Research Education and Extension Service, pro-
grams to protect the food supply of the United States by
conducting activities to—
(1) enhance the capability of the Service to re-
spond immediately to the needs of Federal regulatory
agencies involved in protecting the food and agricul-
tural system;
(2) continue existing partnerships with institu-
tions of higher education (including partnerships
with 3 institutions of higher education that are na-
tional centers for countermeasures against agricul-
tural bioterrorism and 7 additional institutions with
existing programs related to bioterrorism) to help
form stable, long-term programs of research, develop-
ment, and evaluation of options to enhance the bio-
security of United States agriculture;
(3) strengthen linkages with the intelligence com-
munity to better identify research needs and evaluate
acquired materials;
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(4) expand Service involvement with inter-
national organizations dealing with plant and ani-
mal disease control; and
(5) otherwise expand the capacity of the Service
to protect against the threat of bioterrorism.
(b) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section,
$190,000,000 for fiscal year 2002, and such sums as may
be necessary for each subsequent fiscal year.
Attest:
Secretary.