I
107TH CONGRESS
1ST SESSION
H. R. 3310
To improve the ability of the United States to prepare for and respond
to a biological threat or attack.
IN THE HOUSE OF REPRESENTATIVES
NOVEMBER 16, 2001
Mr. GANSKE (for himself, Mr. BERRY, Mr. WAMP, Mr. ROEMER, Mr.
COOKSEY, Mr. MCDERMOTT, Mr. QUINN, Mr. ANDREWS, Mr. GRAHAM,
Mr. BOSWELL, Mr. LEACH, Mrs. ROUKEMA, Mr. KING, Mr. WELDON of
Florida, Mr. SHAYS, Mrs. MORELLA, Mr. DOOLEY of California, Mr.
SANDLIN, and Mr. SABO) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce, and in addition to
the Committees on the Judiciary, and Agriculture, for a period to be sub-
sequently determined by the Speaker, in each case for consideration of
such provisions as fall within the jurisdiction of the committee concerned
A BILL
To improve the ability of the United States to prepare for
and respond to a biological threat or attack.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Bioterrorism Preparedness Act of 2001’’.
(b) TABLE OF CONTENTS.—The table of contents of
the Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I—NATIONAL GOALS FOR BIOTERRORISM PREPAREDNESS
Sec. 101. Amendment to the Public Health Service Act.
TITLE II—IMPROVING THE FEDERAL RESPONSE TO
BIOTERRORISM
Sec. 201. Additional authorities of the Secretary; Strategic National Pharma-
ceutical Stockpile.
Sec. 202. Improving the ability of the Centers for Disease Control and Preven-
tion to respond effectively to bioterrorism.
Subtitle B—Coordination of Efforts and Responses
Sec. 211. Assistant Secretary of Emergency Preparedness; National Disaster
Medical 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
warfare 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.
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 facili-
ties.
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 inspec-
tions.
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:
‘‘TITLE XXVIII—STRENGTHENING
THE 
NATION’S 
PREPARED-
NESS FOR BIOTERRORISM
‘‘SEC. 2801. CONGRESSIONAL FINDINGS ON BIOTERRORISM
PREPAREDNESS.
‘‘Congress finds that the United States should fur-
ther develop and implement a coordinated strategy to pre-
vent, and if necessary, to respond to biological threats or
attacks upon the United States. Such strategy should in-
clude measures for—
‘‘(1) enabling the Federal Government to pro-
vide 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 bio-
logical threats or attacks.’’.
TITLE II—IMPROVING THE FED-
ERAL RESPONSE TO BIOTER-
RORISM
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 national, State, and local levels toward achieving the
national goal of bioterrorism preparedness, including ac-
tions to strengthen the preparedness of rural communities
for a biological 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 re-
port 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
section 319 to protect the public health in the
event that a condition described in section
319(a) occurs.
‘‘(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
transport, hospital or laboratory capacity, lack of in-
tegration of Federal or State public health networks,
workforce 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
Disaster Response Medical Volunteer Service that
would be a private-sector, community-based rapid re-
sponse corps of medical volunteers.
‘‘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,
including 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 emer-
gency.
‘‘(b) RULE
OF CONSTRUCTION.—Nothing in sub-
section (a) shall be construed to prohibit the Secretary
from including in the stockpile described in such sub-
section such vaccines, 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 ‘stock-
pile’ 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
contract at such time as shall be specified in the
contract.
‘‘(d) PROCEDURES.—The Secretary, in managing the
stockpile under this section, shall—
‘‘(1) ensure that adequate procedures are fol-
lowed with respect to the stockpile maintained under
subsection (a) for inventory management, account-
ing, 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,
$643,000,000 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)—
(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
public 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 labora-
tories.
‘‘(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.
‘‘(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) permanently improve any building or
other facility.
‘‘(6) SUPPLEMENT NOT SUPPLANT.—Funds ap-
propriated under this subsection shall be used to
supplement 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, $60,000,000 for fiscal year 2002,
and such sums as may be necessary for each of fis-
cal 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 sen-
tence:
‘‘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.’’.
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
advice and consent of the Senate, shall appoint an indi-
vidual to serve as the Assistant Secretary for Emergency
Preparedness 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 Prepared-
ness shall—
‘‘(1) serve as the principal adviser to the Sec-
retary on matters relating to emergency prepared-
ness, including preparing for and responding to bio-
logical threats or attacks and for developing policy;
and
‘‘(2) coordinate all functions within the Depart-
ment of Health and Human Services relating to
emergency preparedness, including preparing for and
responding to biological threat 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 Med-
ical System (in this section referred to as the ‘Na-
tional System’) which shall be coordinated by the
Secretary, in collaboration with the Secretary of De-
fense, the Secretary of Veterans Affairs, and the Di-
rector of the Federal Emergency Management Agen-
cy.
‘‘(2) FUNCTIONS.—The National System shall
provide appropriate health services, health-related
social services and, if necessary, auxiliary services
(including mortuary and veterinary services) to re-
spond 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 nec-
essary to prepare for the provision of such services.
‘‘(b) 
TEMPORARY
DISASTER-RESPONSE
PER-
SONNEL.—
‘‘(1) IN GENERAL.—For the purpose of assist-
ing the Office of Emergency Preparedness and the
National System in carrying out duties under this
section, the Secretary may in accordance with this
subsection appoint individuals to serve as temporary
personnel of such Office or System. The Secretary
may make such appointments without regard to the
provisions of title 5, United States Code, governing
appointments in the competitive service, and without
regard to the provisions of chapter 51 and sub-
chapter III of chapter 53 of such title relating to
classification and General Schedule pay rates.
‘‘(2) TRAVEL
AND
SUBSISTENCE.—An indi-
vidual appointed under paragraph (1) shall, in ac-
cordance with subchapter I of chapter 57 of title 5,
United States Code, be eligible for travel, subsist-
ence, and other necessary expenses incurred in car-
rying out the duties for which the individual was ap-
pointed, including per diem in lieu of subsistence.
‘‘(3) LIABILITY.—For purposes of section
224(a) and the remedies described in such section,
an individual appointed under paragraph (1) shall,
while acting within the scope of such appointment,
be considered to be an employee of the Public
Health Service performing medical, surgical, dental,
or related functions. Participation in training pro-
grams carried out by the Office of Emergency Pre-
paredness or Federal personnel of the National Sys-
tem shall be considered within the scope of such an
appointment (regardless of whether the individual
receives compensation for such participation).
‘‘(c) 
TEMPORARY
DISASTER-RESPONSE
AP-
POINTEE.—For purposes of this section, the term ‘tem-
porary 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
sustained 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 re-
sponsible for making determinations as to whether the
claimants are entitled 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 serv-
ice, be deemed a person performing ‘service in the
uniformed services’ for purposes of chapter 43 of
title 38, United States Code, pertaining to employ-
ment and reemployment rights of members in the
uniformed services. All rights and obligations of such
persons and procedures for assistance, enforcement,
and investigation shall be as provided for in chapter
43 of title 38, United States Code.
‘‘(2) NOTICE OF ABSENCE FROM POSITION OF
EMPLOYMENT.—Preclusion of giving notice of serv-
ice by disaster response necessity shall be deemed
preclusion by ‘military necessity’ for purposes of sec-
tion 4312(b) of title 38, United States Code, per-
taining to giving notice of absence from a position
of employment. A determination of disaster response
necessity shall be made pursuant to regulations pre-
scribed by the Secretary, in consultation with the
Secretary of Defense, and shall not be subject to ju-
dicial review.
‘‘(f) LIMITATION.—A temporary disaster-response
appointee 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
section.’’.
SEC. 212. EXPANDED AUTHORITY OF THE SECRETARY OF
HEALTH AND HUMAN SERVICES TO RESPOND
TO PUBLIC HEALTH EMERGENCIES.
(a) PROVISION OF DECLARATION TO CONGRESS.—
Section 319(a) of the Public Health Service Act (42
U.S.C. 247d(a)) is amended by adding at the end the fol-
lowing: ‘‘Not later than 48 hours after a declaration of
a public health emergency under this section, the Sec-
retary shall provide a written declaration to Congress indi-
cating that an emergency under this section has been de-
clared.’’.
(b) WAIVER OF REPORTING DEADLINES.—Section
319 of the Public Health Service Act (42 U.S.C. 247d)
is amended 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 sub-
section (a), individuals or public or private entities are un-
able to comply with deadlines for the submission to the
Secretary of data or reports required under any law ad-
ministered by the Secretary, the Secretary may, notwith-
standing any other provision of law, grant such extensions
of such deadlines as the circumstances reasonably require,
and may waive any sanctions otherwise applicable to such
failure to comply.’’.
(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 add-
ing at the end the following:
‘‘(e) EMERGENCY DECLARATION PERIOD.—A deter-
mination by the Secretary under subsection (a) that a
public 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
Secretary if—
‘‘(1) the Secretary determines that such an ex-
tension is appropriate; and
‘‘(2) the Secretary provides a written notifica-
tion to Congress within 48 hours of such exten-
sion.’’.
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
Secretary, in coordination with the Secretary of Defense,
the Director of the Federal Emergency Management
Agency, the Attorney General, the Secretary of Veterans
Affairs, the Secretary of Labor, and the Secretary of Agri-
culture, and with other similar Federal officials as deter-
mined appropriate, shall establish a joint interdepart-
mental 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 pur-
chase of priority countermeasures;
‘‘(3) coordinate research on pathogens likely to
be used in a biological threat or attack on the civil-
ian 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 respond (including mental health response) to a
biological threat or attack;
‘‘(7) in the recognition that medical and public
health professionals are likely to provide much of the
first response to such an attack, develop, coordinate,
enhance, and assure the quality of joint planning
and training programs that address the public
health and medical consequences of a biological
threat or attack on the civilian population between—
‘‘(A) local firefighters, ambulance per-
sonnel, police and public security officers, or
other emergency response personnel; and
‘‘(B) hospitals, primary care facilities, and
public health agencies;
‘‘(8) coordinate the development of strategies
for Federal, State, and local agencies to commu-
nicate information to the public regarding biological
threats or attacks;
‘‘(9) develop methods to decontaminate facilities
contaminated as a result of a biological attack, in-
cluding appropriate protections for the safety of
those conducting such activities; and
‘‘(10) ensure that the activities under this sub-
section address the needs of children and other vul-
nerable populations.
The working group shall carry out paragraphs (1) and (2)
in consultation with the pharmaceutical, biotechnology,
and medical device industries, and other appropriate ex-
perts.
‘‘(b) ADVICE TO THE FEDERAL GOVERNMENT.—The
Secretary shall establish advisory committees to provide
expert recommendations to the Secretary to assist the Sec-
retary, including 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
appropriate to address the special needs of chil-
dren, and child health experts on infectious dis-
ease, environmental health, toxicology, and
other relevant 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 relates to children;
‘‘(ii) needed changes to the health
care and emergency medical service sys-
tems and emergency medical services pro-
tocols to meet the special needs of children
with respect to a biological threat or at-
tack; and
‘‘(iii) changes, if necessary, to the Na-
tional Pharmaceutical Stockpile, to meet
the special needs of children.
‘‘(2) EMERGENCY
PUBLIC
INFORMATION
AND
COMMUNICATIONS TASK FORCE.—
‘‘(A) IN GENERAL.—The Emergency Pub-
lic Information and Communications (EPIC)
Task Force, which shall be composed of individ-
uals with expertise in public health, communica-
tions, behavioral psychology, and other areas
determined 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 bi-
ological threats or attacks to the public, includ-
ing public service announcements or other ap-
propriate means to communicate in a manner
that maximizes information and minimizes
panic, and includes information relevant to chil-
dren and other vulnerable populations.’’.
‘‘(3) SUNSET.—Each Task Force established
under paragraphs (1) and (3) shall terminate on the
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
bioterrorism, either directly or through provision of a
grant to an entity that has expertise in bioterrorism and
the development of websites, that should include informa-
tion relevant to diverse populations (including messages
directed at the general public and such relevant groups
as medical personnel, public safety workers, and agricul-
tural 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 1996; CODIFICATION IN THE PUBLIC HEALTH SERV-
ICE ACT, WITH AMENDMENTS.—
(1) PUBLIC HEALTH SERVICE ACT.—Subpart 1
of part F of title III of the Public Health Service
Act (42 U.S.C. 262 et seq.) is amended by inserting
after section 351 the following:
‘‘SEC. 351A. ENHANCED CONTROL OF 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
subparagraph (A), the Secretary shall—
‘‘(i) consider—
‘‘(I) the effect on human health
of exposure to the agent or toxin;
‘‘(II) the degree of contagious-
ness of the agent or toxin and the
methods by which the agent or toxin
is transferred to humans;
‘‘(III) the availability and effec-
tiveness of 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
vulnerable populations, that the Sec-
retary considers appropriate; and
‘‘(ii) consult with appropriate Federal
departments and agencies, and scientific
experts representing appropriate profes-
sional groups, including those with pedi-
atric expertise.
‘‘(2) BIENNIAL REVIEW.—The Secretary shall
review and republish the list under paragraph (1) bi-
ennially, or more often as needed, and shall, through
rulemaking, revise the list as necessary to incor-
porate additions or deletions to ensure public health,
safety, and security.
‘‘(3) EXEMPTIONS.—The Secretary may exempt
from the list under paragraph (1)—
‘‘(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
amended in 1985 by the Food Safety and Secu-
rity Act.’’;
‘‘(b) REGULATION OF TRANSFERS OF LISTED BIO-
LOGICAL AGENTS AND TOXINS.—The Secretary shall by
regulation provide for—
‘‘(1) the establishment and enforcement of safe-
ty procedures for the transfer of biological agents
and toxins listed pursuant to subsection (a)(1), in-
cluding measures to ensure—
‘‘(A) proper training and appropriate skills
to handle such agents and toxins; and
‘‘(B) proper laboratory facilities to contain
and dispose of such agents and toxins;
‘‘(2) safeguards to prevent access to such
agents and toxins for use in domestic or inter-
national terrorism or for any other criminal purpose;
‘‘(3) the establishment of procedures to protect
the public safety in the event of a transfer or poten-
tial transfer of a biological agent or toxin in viola-
tion of the safety procedures established under para-
graph (1) or the safeguards established under para-
graph (2); and
‘‘(4) appropriate availability of biological agents
and toxins for research, education, and other legiti-
mate purposes.
‘‘(c) POSSESSION AND USE OF LISTED BIOLOGICAL
AGENTS AND TOXINS.—The Secretary shall by regulation
provide for the establishment and enforcement of stand-
ards and procedures governing the possession and use of
biological agents and toxins listed pursuant to subsection
(a)(1) in order to protect the public health and safety, in-
cluding the measures, safeguards, procedures, and avail-
ability of such agents and toxins described in paragraphs
(1) through (4) of subsection (b), respectively.
‘‘(d) REGISTRATION
AND TRACEABILITY MECHA-
NISMS.—Regulations under subsections (b) and (c) shall
require registration of the possession, use, and transfer
of biological agents and toxins listed pursuant to sub-
section (a)(1), and such registration shall include (if avail-
able to the registered person) information regarding the
characterization of such biological agents and toxins to fa-
cilitate their identification and traceability. The Secretary
shall maintain a national database of the location of such
biological 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 per-
sons under subsection (g).
‘‘(f) EXEMPTIONS.—
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish exemptions, including exemptions from the secu-
rity provisions for the use of attenuated or inactive
biological agents or toxins in biomedical research or
for legitimate medical purposes, from the applica-
bility of provisions of—
‘‘(A) the regulations issued under sub-
section (b) when the Secretary determines that
the exemptions, including exemptions from the
security requirements, are consistent with pro-
tecting public health and safety; and
‘‘(B) the regulations issued under sub-
section (c) when the Secretary determines that
the exemptions, including exemptions from the
security requirements, are consistent with pro-
tecting public health and safety and that the
agent or toxin does not present a threat of use
in domestic or international terrorism.
‘‘(2) CLINICAL LABORATORIES.—The Secretary
shall exempt clinical laboratories and other persons
that possess, use, or transfer biological agents and
toxins listed pursuant to subsection (a)(1) from the
applicability 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 Attor-
ney 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), (c), and (d).
‘‘(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
developed in consultation with research-performing
organizations, including universities, and imple-
mented with timeframes that take into account the
need to continue research and education using bio-
logical agents and toxins listed pursuant to sub-
section (a)(1).
‘‘(h) DISCLOSURE OF INFORMATION.—
‘‘(1) IN
GENERAL.—Any information in the
possession of any Federal agency that identifies a
person, or the geographic location of a person, who
is registered pursuant to regulations under this sec-
tion (including regulations promulgated before the
effective date of this subsection), or any site-specific
information relating to the type, quantity, or charac-
terization of a biological agent or toxin listed pursu-
ant to subsection (a)(1) or the site-specific security
mechanisms in place to protect such agents and tox-
ins, including the national database required in sub-
section (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
‘‘(B) from making disclosures of such in-
formation to any committee or subcommittee of
the Congress with appropriate jurisdiction,
upon request.
‘‘(i) CIVIL PENALTY.—In addition to any other pen-
alties that may apply under law, any person who violates
any provision of a regulation issued under subsection (b)
or (c) shall be subject to the United States for a civil pen-
alty in an amount not exceeding $250,000 in the case of
an individual and $500,000 in the case of any other per-
son.
‘‘(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.—
(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
Secretary of Health and Human Services shall
promulgate an interim final rule for carrying
out section 351A(c) of the Public Health Serv-
ice Act, which amends the Antiterrorism and
Effective Death Penalty Act of 1996. Such in-
terim final rule will take effect 60 days after
the date on which such rule is promulgated, in-
cluding for purposes of—
(i) section 175(b) of title 18, United
States Code (relating to criminal pen-
alties), as added by subsection (b)(1)(B) of
this section; 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
possession under the interim final rule promul-
gated under subparagraph (A), shall submit an
application for such registration not later than
60 days after the date on which such rule is
promulgated.
(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 Effective Death Penalty Act of 1996, and any
regulations, including the list under subsection
(d)(1) of section 511 of that Act, issued under sec-
tion 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
following:
‘‘(b) SELECT AGENTS.—
‘‘(1) UNREGISTERED FOR POSSESSION.—Who-
ever 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 reasons to believe has not ob-
tained a registration required by regulations issued
under section 351A(b) or (c) of the Public Health
Service Act shall be fined under this title, or impris-
oned 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
inserting 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 cul-
tivated, cultured, collected, or otherwise extracted
from its natural source.
‘‘(2) The term ‘for use as a weapon’ includes
the development, production, transfer, acquisition,
retention, or possession of any biological agent,
toxin, or delivery system, other than for prophy-
lactic, protective, 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
subsequently 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 striking ‘‘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 sen-
tence.
(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
other appropriate Federal agencies, shall submit to the
Congress a report that—
(1) describes the extent to which there has been
compliance by governmental and private entities
with applicable regulations under section 351A of
the Public Health Service Act, including the extent
of compliance before the date of the enactment of
this Act, and including the extent of compliance with
regulations promulgated after such date of enact-
ment;
(2) describes the actions to date and future
plans of the Secretary for updating the list of bio-
logical agents and toxins under 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 regulations under such section 351A of the
Public Health Service Act and for taking appro-
priate 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
Service Act.
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 subsection (c) and inserting the following:
‘‘(c) STATE BIOTERRORISM PREPAREDNESS AND RE-
SPONSE BLOCK GRANTS.—
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish the State Bioterrorism Preparedness and Re-
sponse Block Grant Program (referred to in this
subsection as the ‘Program’) under which the Sec-
retary shall award grants to or enter into coopera-
tive agreements with States, the District of Colum-
bia, and territories (referred to in this section as ‘eli-
gible entities’) to enable such entities to prepare for
and respond to biological threats or attacks. The
Secretary shall ensure that activities conducted
under this section are coordinated with the activities
conducted under this section and section 319C.
‘‘(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 State Bioterrorism Preparedness and
Response 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
substantially equivalent as determined by the
Secretary 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;
‘‘(D) use amounts received under para-
graph (1) in accordance with the plan sub-
mitted under paragraph (3), including making
expenditures to carry out the strategy contained
in the plan;
‘‘(E) use amounts received under para-
graph (1) to supplement and not supplant fund-
ing at levels in existence prior to and on Sep-
tember 11, 2001 for public health capacities or
bioterrorism preparedness; 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 re-
ceiving amounts under this subsection, and 1 year
after such date, a State, the District of Columbia,
or a territory shall prepare and submit to the Sec-
retary a Bioterrorism Preparedness and Response
Plan for responding 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-
pacities developed under section 319A, includ-
ing 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 eligible entity will implement using amounts
received in order to detect and respond to bio-
logical threats or attacks, including the manner
in which the eligible entity will manage State
surveillance 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
biological threat or attack, including training
and planning to protect the health and safety of
those conducting such detection and response
activities;
‘‘(D) a description of the cleanup and con-
tamination prevention efforts that may be im-
plemented in the event of a biological threat or
attack;
‘‘(E) a description of efforts to ensure that
hospitals and health care providers have ade-
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 con-
strued 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
eligible entity shall use amounts received under
this section to—
‘‘(i) conduct the assessment under
section 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).
‘‘(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
emergency response activities including bi-
ological threats or attacks, including train-
ing personnel in these and other necessary
functions;
‘‘(ii) carry out activities to improve
communications and coordination efforts
within the eligible entity and between the
eligible entity and the Federal Govern-
ment, including activities to improve infor-
mation technology and communications
equipment available to health care and
public health officials for use in responding
to a biological threat or attack or other
public health emergency and including
early warning and surveillance networks
that use advanced information technology
to provide early detection of biological
threats or attacks;
‘‘(iii) plan for triage and transport
management in the event of a biological
threat or attack;
‘‘(iv) meet the special needs of chil-
dren and other vulnerable populations dur-
ing and after a biological threat or attack,
including the expansion of 2–1–1 call cen-
ters or other universal hotlines, or an al-
ternative communication plan to assist vic-
tims and their families in receiving timely
information;
‘‘(v) improve the ability of hospitals
and other health care facilities to provide
effective 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 simi-
lar organizations; and
‘‘(vi) enhance the safety of workplaces
in the event of a biological threat or at-
tack, except that nothing in this clause
shall be construed to create a new, or devi-
ate from an existing, authority to regulate,
modify, or otherwise effect safety and
health rules and standards.
‘‘(C) PROHIBITED USES.—An eligible enti-
ty may not use amounts received under this
subsection 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) permanently improve any build-
ing or other facility; or
‘‘(v) satisfy any requirement for the
expenditure of non-Federal funds as a con-
dition 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 territory bears to the total popu-
lation of the United States.
‘‘(B) EXCEPTIONS.—
‘‘(i) MINIMUM
AMOUNT
WITH
RE-
SPECT TO STATES.—Notwithstanding sub-
paragraph (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 sub-
ject to the extent of amounts made
available under paragraph (9), the
Secretary 
may 
provide 
additional
funds to a State, District, or territory
under this subsection if the Secretary
determines that such State, District,
or territory has extraordinary needs
with respect to bioterrorism prepared-
ness.
‘‘(II) FINDING WITH RESPECT TO
THE DISTRICT OF COLUMBIA.—As a
result 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
UNEX-
PENDED FUNDS.—To the extent that all the
funds appropriated under paragraph (9) for a
fiscal year and available in such fiscal year are
not otherwise 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;
‘‘(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
‘‘(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 determined under subparagraph (B).
‘‘(B) AMOUNT.—The Secretary shall re-
serve 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.
‘‘(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 organiza-
tion’ have the same meaning given such terms
in section 4(b) and section 4(c) of the Indian
Self-Determination 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.
‘‘(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 ac-
cordance with the requirements of this
subsection. Investigations required by this
clause shall be conducted within the af-
fected entity by qualified investigators.
‘‘(iii) RESPONSE
TO
COMPLAINTS.—
The Secretary shall respond in an expedi-
tious manner to complaints of a substan-
tial 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
entity which has received funds under this sec-
tion, shall make appropriate books, documents,
papers, and records available to the Secretary
or the Comptroller General of the United
States, or any of their duly authorized rep-
resentatives, for examination, copying, or me-
chanical reproduction on or off the premises of
the appropriate entity upon a reasonable re-
quest therefore.
‘‘(C) LIMITATION ON REQUESTS FOR IN-
FORMATION.—
‘‘(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 trans-
mitted in any form not readily available.
‘‘(ii) 
JUDICIAL
PROCEEDINGS.—
Clause (i) does not apply to the collection,
compilation, 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.
‘‘(9) AUTHORIZATION
OF
APPROPRIATIONS.—
There is authorized to be appropriated to carry out
this subsection, $670,000,000 for fiscal year 2002,
and such sums as may be necessary for fiscal year
2003, and no funds are authorized to be appro-
priated 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 nec-
essary 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 MED-
ICAL CENTERS.
Section 319F of the Public Health Service Act (42
U.S.C. 247d–6) is amended—
(1) by redesignating subsections (d) through (h)
and (i), as subsections (e) through (i) and (l), re-
spectively; 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 State Bioterrorism Preparedness and
Response Plan, to improve local and bioterrorism re-
sponse 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;
‘‘(B) prepare, in consultation with the Gov-
ernor or Governors of the State or States in
which the hospital, clinic, health center, or pri-
mary 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 re-
quest of the Secretary or the Governor or Gov-
ernor of the State or States in which the entity
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 bio-
logical attack, and accepting the transfer of pa-
tients, where appropriate.
‘‘(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 National Pharma-
ceutical 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 appro-
priate by the Secretary.
‘‘(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) permanently improve 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 relat-
ing to equipment, training, treatment, capacity, and
personnel, relevant to the status as a bioterrorism
response medical center and the Secretary may pro-
vide technical assistance to eligible entities, including
assistance 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 Re-
lief and Emergency Assistance Act (42 U.S.C. 5196b(b))
is amended—
(1) in paragraph (5), by striking ‘‘and’’ at the
end;
(2) in paragraph (6), by striking the period and
inserting ‘‘; and’’; and
(3) by adding at the end the following:
‘‘(7) include a plan for providing information to
the public in a coordinated manner.’’.
SEC. 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—
(1) by striking ‘‘Not later than 180 days after
the date of the enactment of this section, the’’ and
inserting ‘‘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 de-
scribed in subsection (a) and the efforts made by
such group to carry out the activities described in
such subsection;
‘‘(7) the activities and cost of the 2–1–1 call
centers 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:
‘‘(h) RESEARCH RELATING TO BIOLOGICAL THREATS
OR ATTACKS IN THE WORKPLACE.—The Director shall
enhance 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 uni-
versity centers and laboratories will contribute sig-
nificantly to the United States capacity to defend
against any biological threat;
(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 Prepared-
ness Act of 2001; and
(4) Congress recognizes the importance of exist-
ing public university-based research, training, public
awareness, and safety related biological defense pro-
grams in the awarding of grants and contracts made
in accordance with this Act.
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 Sec-
retary may conduct meetings and consultations
with parties involved in the development of pri-
ority countermeasures for the purpose of the
development, manufacture, distribution, pur-
chase, or sale of priority countermeasures con-
sistent with the purposes of this title. The Sec-
retary 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 ‘Chair-
person’).
‘‘(B) MEETING AND CONSULTATION CON-
DITIONS.—A meeting or consultation conducted
under subparagraph (A) shall—
‘‘(i) be chaired or, in the case of a
consultation, 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, dis-
tribution, or sale of priority counter-
measures, consistent with the purposes of
this title; and
‘‘(v) be conducted in such manner as
to ensure that national security, confiden-
tial, and proprietary information is not dis-
closed outside the meeting or consultation.
‘‘(C) 
MINUTES.—The 
Secretary 
shall
maintain 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 agree-
ment or conduct that results from a meeting or
consultation and that does not receive an ex-
emption pursuant 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 con-
sistent with this paragraph, with the Attorney Gen-
eral 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 pur-
pose 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
agreement;
‘‘(D) an explanation of the necessity of a
cooperative effort among the particular partici-
pating parties to achieve the objectives of the
agreement; and
‘‘(E) any other relevant information deter-
mined necessary by the Secretary in consulta-
tion with the Attorney General and the Chair-
person.
‘‘(3) DETERMINATION.—The Attorney General,
in consultation with the Chairperson, shall determine
whether an agreement regarding covered activities
referred 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, lim-
ited to the performance of the agreement con-
sistent 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 exemp-
tion from the antitrust laws under paragraph
(3) within 15 days of the receipt of such re-
quest.
‘‘(B) EXTENSION.—The Attorney General
may extend the 15-day period referred to in
subparagraph (A) for an additional period of
not to exceed 10 days. Such additional period
may be further extended only by the United
States district court, upon an application by the
Attorney General after notice to the Secretary
and the parties involved.
‘‘(C) DETERMINATION.—In granting an
exemption under this paragraph, the Attorney
General, in consultation with the Chairperson
and the Secretary, must find—
‘‘(i) that the agreement involved is
necessary to ensure the availability of pri-
ority countermeasures;
‘‘(ii) that the exemption from the
antitrust laws would promote the public in-
terest;
‘‘(iii) that there is no substantial com-
petitive impact to areas not directly related
to the purposes of the agreement; and
‘‘(iv) any other factors determined rel-
evant by the Attorney General and the
Chairperson.
‘‘(5) LIMITATION ON AND RENEWAL OF EXEMP-
TIONS.—An exemption granted under paragraph (4)
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 in-
tervals thereafter, if renewed) unless the Attorney
General in consultation with the Chairperson deter-
mines that the exemption should be renewed (with
modifications, as appropriate) considering the fac-
tors described 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 pur-
poses other than those specified in the antitrust ex-
emption granted by the Attorney General shall be
subject to the antitrust laws and any other applica-
ble 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 Con-
gress on the use and continuing need for the exemp-
tion from the antitrust laws provided by this sub-
section.
‘‘(9) SUNSET.—The authority of the Attorney
General to grant or renew a limited antitrust exemp-
tion under this subsection shall expire at the end of
the 6-year period that begins on the date of enact-
ment 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
includes the Act of June 19, 1936 (15 U.S.C.
13 et seq.) commonly known as the Robinson-
Patman 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 competition; 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, in-
cluding attempting to make, making, or per-
forming a contract or agreement or engaging in
other conduct, for the purpose of—
‘‘(i) theoretical analysis, experimen-
tation, or the systematic study of phe-
nomena or observable facts necessary to
the 
development 
of 
priority 
counter-
measures;
‘‘(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
development 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 serv-
ices necessary to the development of pri-
ority countermeasures;
‘‘(vi) the collection, exchange, and
analysis of research or production informa-
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
covered activities described in clauses (i)
through (vi), the conduct of such covered activi-
ties on a protracted and proprietary basis, and
the processing of applications for patents and
the granting of licenses for the results of such
covered activities.
‘‘(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 activi-
ties.
‘‘(ii) Entering into any agreement or
engaging in any other conduct—
‘‘(I) to restrict or require the
sale, licensing, or sharing of inven-
tions, developments, products, proc-
esses, 
or 
services 
not 
developed
through, produced by, or distributed
or sold through such covered activi-
ties; or
‘‘(II) to restrict or require par-
ticipation by any person who is a
party to such covered activities in
other research and development activi-
ties, that is not reasonably necessary
to prevent the misappropriation of
proprietary information contributed
by any person who is a party to such
covered activities or of the results of
such covered activities.
‘‘(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
carry out the purpose of such covered ac-
tivities.
‘‘(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
antitrust laws by a determination under
subsection (i)(4).
‘‘(vi) Except as otherwise provided in
this subsection, entering into any agree-
ment or engaging in any other conduct to
restrict or require participation by any per-
son who is a party to such activities, in
any unilateral or joint activity that is not
reasonably necessary to carry out the pur-
pose 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.
‘‘(4) PERSON.—The term ‘person’ has the
meaning given such term in subsection (a) of the
first section 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 fur-
ther amended by adding at the end the following:
‘‘Subtitle 
B—Developing 
New
Countermeasures Against Bio-
terrorism
‘‘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 include the number of doses of vaccine against
smallpox and other such vaccines determined by the Sec-
retary to be sufficient 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 ex-
tent the Secretary determines necessary to achieve the
purposes of this title, enter into long-term contracts and
comparable grants or cooperative agreements, for the pur-
pose of—
‘‘(1) ensuring the development of priority coun-
termeasures that are necessary to prepare for a bio-
terrorist attack or other significant disease emer-
gency;
‘‘(2) securing the manufacture, distribution,
and adequate supply of such countermeasures, in-
cluding through the development of novel production
methods for such countermeasures;
‘‘(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 con-
tractor does not develop the countermeasure involved.
Such a contract 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 countermeasure; 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-
duction, distribution, or storage of priority counter-
measures.
‘‘(b) BEST PRACTICES.—The Secretary shall develop
guidelines and best practices to enable entities eligible for
funding 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’’.
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 coop-
erative agreements for, research, investigations,
experiments, demonstrations, and studies in the
health sciences relating to—
‘‘(i) the epidemiology and patho-
genesis of biological agents or toxins of po-
tential 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 bio-
terrorist attack;
‘‘(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 chil-
dren 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
Federal 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.
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 designated 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
application 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 Efficacy of New Drugs for Use Against Le-
thal or Permanently Disabling Toxic Substances When Ef-
ficacy 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 fur-
ther amended by adding at the end the following:
‘‘Subtitle C—Miscellaneous
Provisions
‘‘SEC. 2851. SUPPLEMENT NOT SUPPLANT.
‘‘Funds appropriated under this title shall be used
to supplement and not supplant other Federal, State, and
local public funds provided for activities under this title.’’.
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
Secretary of Commerce, and the Secretary of Transpor-
tation, shall, in consultation with the food industry and
consumer and producer groups, and the States, develop
a crisis communications and education strategy with re-
spect to bioterrorist threats to the food supply. Such strat-
egy shall address threat assessments, response and notifi-
cation 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
Agriculture, the Secretary of Health and Human Services,
and the Administrator of the Environmental Protection
Agency.
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
introduction 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
(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 sur-
veillance, incident management, and emergency re-
sponse system.
(2) EXPANSION
OF
SYSTEM.—The Secretary
shall expand the system implemented under para-
graph (1) as soon as practicable to include other
Federal agencies and the States where appropriate
and necessary to enhance the protection of the food
and agriculture system of the United States. To fa-
cilitate the expansion of the system, the Secretary
shall award grants to States.
(c) AUTOMATED RECORDKEEPING SYSTEM.—The
Administrator of the Animal and Plant Health Inspection
Service shall implement a central automated record-
keeping 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 Sec-
retary shall ensure that such a system shall be fully acces-
sible 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 In-
spection Service through the conduct of activities to—
(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 in-
spect 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—
(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 Govern-
ment, the States, and Indian tribes with shared re-
sponsibilities.
(b) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section,
$60,000,000 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 $180,000,000
to enable the Agricultural Research Service to conduct
building upgrades to modernize existing biosecurity facili-
ties and for renovation, updating, and expansion of the
Biosafety Level 3 laboratory and animal research facilities
at the Plum Island Animal Disease Center (Greenport,
New York), the Agricultural Research Service/Animal and
Plant Health Inspection Service facility in Ames, Iowa, the
planning and design of an Agricultural Research Service
biocontainment laboratory for poultry research in Athens,
Georgia, and the planning, updating, and renovation of
the Arthropod-Bome Animal Disease Laboratory in Lar-
amie, Wyoming.
SEC. 516. BIOSECURITY UPGRADES AT THE DEPARTMENT
OF HEALTH AND HUMAN SERVICES.
The Secretary of Health and Human Services shall
take such actions to secure existing facilities of the De-
partment 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.
(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, of 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
completed 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 de-
velop a national inventory of hazardous biological agents
and toxins contained in agricultural research facilities.
Such activities shall include developing and distributing a
model inventory procedure, developing secure means of
transmitting inventory information, and conducting an-
nual inventory activities. The inventory shall be developed
in coordination with, or as a component of, similar sys-
tems in existence on the date of enactment of this Act.
(c) SCREENING PROTOCOL.—The Secretary shall es-
tablish a national protocol for the screening of individuals
who require access to agricultural research facilities in a
manner that provides for the protection of personal pri-
vacy.
(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 inten-
tional 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 out-
break. Biosecurity for livestock includes animal
quarantine procedures, 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 Sec-
retary shall develop and disseminate through edu-
cational 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 biosecurity issues to be distributed to local crop
producers 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 distribu-
tors, and other entities regulated by the Secretary for pur-
poses of ensuring the safety of food through the develop-
ment and implementation of educational programs to en-
sure the security of their facilities and modes of transpor-
tation against potential bioterrorist 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 trans-
portation against potential bioterrorist attacks.
(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.
Subtitle B—Protection of the Food
Supply
SEC. 531. ADMINISTRATIVE DETENTION.
(a) EXPANDED AUTHORITY.—Section 304 of the
Federal Food, Drug and Cosmetic Act (21 U.S.C. 334)
is amended by adding at the end the following:
‘‘(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 em-
ployee, if the officer or qualified employee has cred-
ible evidence or information indicating that the arti-
cle 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
SECRETARY OR SECRETARY’S DESIGNEE.—
‘‘(A) DURATION.—An article of food may
be detained under this subsection for a reason-
able period, not to exceed 20 days, unless a
greater period of time, not to exceed 30 days,
is necessary to enable the Secretary to institute
an action 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 ad-
verse health consequences or death to humans
or animals.
‘‘(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 la-
beled or marked as detained, and may require that
the article 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 release by the Sec-
retary, or the expiration of the detention period ap-
plicable to such order, whichever occurs first.
‘‘(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
violation 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 de-
tained.’’.
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—
(A) by striking the period at the end of
subparagraph (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 impor-
tation 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
serious 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
‘‘DEBARMENT’’; 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
Cosmetic Act (21 U.S.C. 335a(c)(2)(A)(iii)) is
amended by striking ‘‘subsection (b)(2)’’ and insert-
ing ‘‘subsection (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 inserting ‘‘subsections (f) and (g), and sub-
section (b)(1)(C)’’.
(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 amend-
ed by adding at the end the following:
‘‘SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.
‘‘(a) IN GENERAL.—If the Secretary has reason to
believe 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 em-
ployee duly designated by the Secretary, permit such offi-
cer or employee, upon presentation of appropriate creden-
tials and a written notice to such person, at reasonable
times and within reasonable limits and in a reasonable
manner, to have access to and to copy all records relating
to such food that may assist the Secretary to determine
the cause and scope of the violation. This requirement ap-
plies to all records relating to such manufacture, proc-
essing, packing, distribution, receipt, holding, or importa-
tion of such food maintained by or on behalf of such per-
son in any format (including paper and electronic formats)
and at any location.
‘‘(b) 
REGULATIONS
CONCERNING
RECORD-
KEEPING.—The Secretary shall promulgate regulations re-
garding the maintenance and retention of records for in-
spection for not longer than 2 years by persons (excluding
restaurants and farms) that manufacture, process, pack,
transport, distribute, 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
adulterated or misbranded to the extent that it pre-
sents 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 em-
ployees.
‘‘(c) LIMITATIONS.—Nothing in this section shall be
construed—
‘‘(1) to limit the authority of the Secretary to
inspect 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
requirements with respect to a food to the extent
that it is within the exclusive jurisdiction of the Sec-
retary of Agriculture pursuant to the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), or
the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.);
‘‘(3) to 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
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a))
is amended—
(1) in paragraph (1), by adding after the first
sentence the following: ‘‘In the case of any person
(excluding restaurants and farms) that manufac-
tures, processes, packs, transports, distributes, re-
ceives, holds, or imports foods, the inspection shall
extend to all records and other information described
100
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-
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
101
category (as identified under section 170.3 of title
21, Code of Federal Regulations) of any food manu-
factured, processed, or handled at such facility. The
registrant shall notify the Secretary in a timely man-
ner of changes to such information.
‘‘(3) PROCEDURE.—Upon receipt of a com-
pleted registration described in paragraph (1), the
Secretary shall notify the registrant of the receipt of
such registration and assign a registration number
to each registered facility.
‘‘(4) LIST.—The Secretary shall compile and
maintain an up-to-date list of facilities that are reg-
istered under this section. Such list and other infor-
mation required to be submitted under this sub-
section shall not be subject to the disclosure require-
ments of section 552 of title 5, United States Code.
‘‘(b) EXEMPTION AUTHORITY.—The Secretary may
by regulation exempt types of retail establishments or
farms from the requirements of subsection (a) if the Sec-
retary determines 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),
102
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 re-
quire an application, review, or licensing process.’’.
(b) MISBRANDED FOODS.—Section 403 of the Fed-
eral 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 registra-
tion has not been submitted to the Secretary under section
415(a).’’.
(c) EFFECTIVE DATE.—The amendment made by
subsection (b) shall take effect 180 days after the date
of enactment of this Act.
SEC. 535. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.
(a) PRIOR
NOTICE
OF
IMPORTED
FOOD
SHIP-
MENTS.—Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by adding at
the end the following:
‘‘(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 ship-
per of the food shall provide documentation to the
103
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 may require by regulation.
‘‘(2) REFUSAL OF ADMISSION.—If documenta-
tion is not provided as required by paragraph (1) at
least 4 hours before the food is imported or offered
for importation, 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
Meat Inspection Act (21 U.S.C. 601 et seq.), the
Poultry Products Inspection Act (21 U.S.C. 451 et
seq.), or the Egg Products Inspection Act (21
U.S.C. 1031 et seq.).’’.
(b) PROHIBITION
OF KNOWINGLY FALSE STATE-
MENTS.—Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by section
104
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 Fed-
eral 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 sec-
tion 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 ani-
mals.’’.
(b) REQUIREMENT.—Section 801(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is
amended by adding at the end the following: ‘‘The Sec-
retary of Health and Human Services may require the
owner or consignee of a food that has been refused admis-
sion under this section, and has not been required to be
105
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 sec-
tion shall be construed to limit the authority of the Sec-
retary of Health and Human Services or the Secretary of
the Treasury to require the marketing of refused articles
under any other provision of law.
SEC. 537. AUTHORITY TO COMMISSION OTHER FEDERAL
OFFICIALS TO CONDUCT INSPECTIONS.
Section 702(a) of the Federal Food, Drug and Cos-
metic Act (21 U.S.C. 372(a)) is amended in the first
sentence—
(1) by inserting ‘‘qualified’’ before ‘‘employees’’;
and
(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 ‘‘offi-
cers and employees of the Department’’.
106
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
further 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),
unless 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 re-
quirements 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 recog-
nized Indian tribes that undertake to examinations, in-
spections, and investigations, and related activities under
section 702, the funds provided under such grants to be
available only for the costs of conducting such examina-
tions, inspections, investigations, and related activities.
‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated $10,000,000 for fiscal
107
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 sec-
tion 317P the following:
‘‘SEC. 317Q. FOOD SAFETY GRANTS.
‘‘(a) IN GENERAL.—The Secretary may award food
safety grants to States to expand the number of States
participating in Pulsenet, the Foodborne Diseases Active
Surveillance Network, and other networks to enhance Fed-
eral, State, and local food safety efforts.
108
‘‘(b) USE OF FUNDS.—Funds awarded under this
section 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 need-
ed to participate in Pulsenet, Foodborne Diseases Active
Surveillance Network, and other networks to enhance Fed-
eral, State, and local food safety efforts.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There
is authorized to be appropriated to carry out this section,
such sums as may be necessary for each fiscal year.
‘‘SEC. 317R. SURVEILLANCE OF ANIMAL AND HUMAN
HEALTH.
‘‘(a) IN GENERAL.—The Secretary, through the
Commissioner of the Food and Drug Administration and
the Director of the Centers for Disease Control and Pre-
vention, and the Secretary of Agriculture shall develop and
implement a plan for coordinating the surveillance for
zoonotic disease and human disease.
‘‘(b) 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 subsequent fiscal year.’’.
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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 au-
thorities to expand Agricultural Research Service, and Co-
operative State Research Education and Extension Serv-
ice, programs 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 regu-
latory agencies involved in protecting the food and
agricultural 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, devel-
opment, and evaluation of options to enhance the
biosecurity of United States agriculture;
(3) strengthen linkages with the intelligence
community to better identify research needs and
evaluate acquired materials;
110
(4) expand Service involvement with inter-
national organizations dealing with plant and animal
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.
Æ