Public Health Security and Bioterrorism Preparedness and Response Act of 2002
PL 107-188 (H.R.3448), enacted 06/12/2002

116 STAT. 594 
PUBLIC LAW 107-188-JUNE 12, 2002 
Public Law 107-188 
107th Congress 
June 12, 2002 
IH.R. 3448] 
Public Health 
Security and 
Bioterrorism 
Preparedness 
and Response Act 
of2002. 
42 u s e 201 note. 
An Act 
To improve the ability of the United States to prevent, prepare for, and respond 
to bioterrorism and other pubhc health emergencies. 
Be it enacted by the Senate and House of Representatives 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 "Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002". 
(b) TABLE OF CONTENTS.—The table of contents of the Act 
is as follows: 
Sec. 1. Short title; table of contents. 
T I T L E I—NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER 
PUBLIC HEALTH EMERGENCIES 
Subtitle A—^National Preparedness and Response Planning, Coordinating, and 
Reporting 
Sec. 101. National preparedness and response. 
Sec. 102. Assistant Secretary for Public Health Emergency Preparedness; National 
Disaster Medicad System. 
Sec. 103. Improving abiUty of Centers for Disease Control and Prevention. 
Sec. 104. Advisory committees and communications; study regarding communica-
tions abilities of public health agencies. 
Sec. 105. Education of health care personnel; training regarding pediatric issues. 
Sec. 106. Grants regarding shortages of certain health professionals. 
Sec. 107. Emergency system for advance registration of health professions volun-
teers. 
Sec. 108. Working group. 
Sec. 109. Antimicrobial resistance. 
Sec. 110. SuppUes and services in Ueu of award fimds. 
Sec. 111. Additional amendments. 
Subtitle B—Strategic National Stockpile; Development of Priority Countermeasures 
Sec. 121. Strategic national stockpile. 
Sec. 122. Accelerated approval of priority countermeasures. 
Sec. 123. Issuance of rule on animal trials. 
Sec. 124. Security for countermeasure development and production. 
Sec. 125. Accelerated coimtermeasure research and development. 
Sec. 126. Evaluation of new and emerging technologies regarding bioterrorist 
attack and other public health emergencies. 
Sec. 127. Potassium iodide. 
Subtitle C—Improving State, Local, and Hospital Preparedness for and Response to 
Bioterrorism and Other Public Health Emergencies 
Sec. 131. Grants to improve State, local, and hospital preparedness for and 
response to bioterrorism and other public health emergencies. 
Subtitle D—Emergency Authorities; Additional Provisions 
Sec. 141. Reporting deadlines. 
Sec. 142. Streamlining and clarifying communicable disease quarantine provisions. 
PUBLIC LAW 107-188-JUNE 12, 2002 
116 STAT. 595 
Sec. 143. Emergency waiver of Medicare, Medicaid, and SCHIP requirements. 
Sec. 144. Provision for expiration of public health emergencies. 
Subtitle E—^Additional Provisions 
Sec. 151. Designated State public emergency announcement plan. 
Sec. 152. Expanded research by Secretary of Energy. 
Sec. 153. Expanded research on worker health and safety. 
Sec. 154. Enhancement of emergency preparedness oi Department of Veterans 
Affairs. 
Sec. 155. Reauthorization of existing program. 
Sec. 156. Sense of Congress. 
Sec. 157. General Accounting Office report. 
Sec. 158. Certain awards. 
Sec. 159. Public access defibrillation programs and public access defibrillation 
demonstration projects. 
TITLE II—ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS 
AND TOXINS 
Subtitle A—Department of Health and Human Services 
Sec. 201. Regulation of certain biological agents and toxins. 
Sec. 202. Implementation by Department of Health and Human Services. 
Sec. 203. Effective dates. 
Sec. 204. Conforming amendment. 
Subtitle B—Department of Agriculture 
Sec. 211. Short title. 
Sec. 212. Regulation of certain biological agents and toxins. 
Sec. 213. Implementation by Department of Agriculture. 
Subtitle C—Interagency Coordination Regarding Overlap Agents and Toxins 
Sec. 221. Interagency coordination. 
Subtitle D—Criminal Penalties Regarding Certain Biological Agents and Toxins 
Sec. 231. Criminal penalties. 
TITLE III—PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG 
SUPPLY 
Subtitle A—Protection of Food Supply 
Sec. 301. Food safety and security strategy. 
Sec. 302. Protection against adulteration of food. 
Sec. 303. Administrative detention. 
Sec. 304. Debarment for repeated or serious food import violations. 
Sec. 305. Registration of food facilities. 
Sec. 306. Maintenance and inspection of records for foods. 
Sec. 307. Prior notice of imported food shipments. 
Sec. 308. Authority to mark articles refused admission into United States. 
Sec. 309. Prohibition against port shopping. 
Sec. 310. Notices to States regarding imported food. 
Sec. 311. Grants to States for inspections. 
Sec. 312. Surveillance and information grants and authorities. 
Sec. 313. Surveillance of zoonotic diseases. 
Sec. 314. Authority to commission other Federal officials to conduct inspections. 
Sec. 315. Rule of construction. 
Subtitle B—Protection of Drug Supply 
Sec. 321. Annual registration of foreign manufacturers; shipping information; drug 
and device listing. 
Sec. 322. Requirement of additional information regarding import components 
intended for use in export products. 
Subtitle C—Greneral Provisions Relating to Upgrade of Agricultural Security 
Sec. 331. Expansion of Animal and Plant Health Inspection Service activities. 
Sec. 332. Expansion of Food Safety Inspection Service activities. 
Sec. 333. Biosecurity upgrades at the Department of Agriculture. 
Sec. 334. Agricultural biosecurity. 
Sec. 335. Agricultural bioterrorism research and development. 
Sec. 336. Animal enterprise terrorism penalties. 
TITLE IV—DRINKING WATER SECURITY AND SAFETY 
Sec. 401. Terrorist and other intentional acts. 
116 STAT. 596 
PUBLIC LAW 107-188—JUNE 12, 2002 
Sec. 402. Other Safe Drinking Water Act amendments. 
Sec. 403. Miscellaneous and technical amendments. 
TITLE V—ADDITIONAL PROVISIONS 
Subtitle A—Prescription Drug User Fees 
Sec. 501. Short title. 
Sec. 502. Findings. 
Sec. 503. Definitions. 
Sec. 504. Authority to assess and use drug fees. 
Sec. 505. Accountability and reports. 
Sec. 506. Reports of postmarketing studies. 
Sec. 507. Savings clause. 
Sec. 508. Effective date. 
Sec. 509. Sunset clause. 
Subtitle B—^Funding Provisions Regarding Food and Drug Administration 
Sec. 521. Office of Drug Safety. 
Sec. 522. Division of Drug Marketing, Advertising, and Communications. 
Sec. 523. Office of Generic Drugs. 
Subtitle C—^Additional Provisions 
Sec. 531. Transition to digital television. 
Sec. 532. 3-year delay in lock in procedures for Medicare+Choice plans; change in 
Medicare+Choice reporting deadlines and annual, coordinated election 
period for 2003, 2004, and 2005. 
TITLE 
I—NATIONAL 
PREPAREDNESS 
FOR 
BIOTERRORISM 
AND 
OTHER 
PUBLIC HEALTH EMERGENCIES 
Subtitle A—National Preparedness and Re-
sponse Planning, Coordinating, and Re-
porting 
SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE. 
(a) IN GENERAL.—The Public Health Service Act (42 U.S.C. 
201 et seq.) is amended by adding at the end the following title: 
"TITLE XXVIII—NATIONAL PREPARED-
NESS 
FOR 
BIOTERRORISM 
AND 
OTHER 
PUBLIC 
HEALTH 
EMER-
GENCIES 
"Subtitle A—National Preparedness 
and 
Response Planning, Coordinating, 
and 
Reporting 
42 u s e 300hh. 
"SEC. 2801. NATIONAL PREPAREDNESS PLAN. 
"(a) IN GENERAL.— 
"(1) 
PREPAREDNESS 
AND 
RESPONSE 
REGARDING 
PUBLIC 
HEALTH EMERGENCIES.—The Secretary shall further develop 
and implement a coordinated strategy, building upon the core 
public health capabilities established pursuant to section 319A, 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 597 
for carrying out health-related activities to prepare for and 
respond effectively to bioterrorism and other public health 
emergencies, including the preparation of a plan under this 
section. The Secretary shall periodically thereafter review and, 
as appropriate, revise the plan. 
"(2) NATIONAL APPROACH.—In carr3dng out paragraph (1), 
the Secretary shall collaborate with the States toward the 
goal of ensuring that the activities of the Secretary regarding 
bioterrorism and other public health emergencies are coordi-
nated with activities of the States, including local governments. 
"(3) EVALUATION OF PROGRESS.—The plan under paragraph 
(1) shall provide for specific benchmarks and outcome measures 
for evaluating the progress of the Secretary and the States, 
including local governments, with respect to the plan under 
paragraph (1), including progress toward achieving the goals 
specified in subsection (b). 
"(b) PREPAREDNESS GOALS.—^The plan under subsection (a) 
should include provisions in furthersmce of the following: 
"(1) Providing effective assistance to State and local govern-
ments in the event of bioterrorism or other public health emer-
gency. 
"(2) Ensuring that State and local governments have appro-
priate capacity to detect and respond effectively to such emer-
gencies, including capacities for the following: 
"(A) Effective public health surveillance and reporting 
mechanisms at the State and local levels. 
"(B) Appropriate laboratory readiness. 
"(C) 
Properly 
trained 
and equipped 
emergency 
response, public health, and medical personnel. 
"(D) 
Health 
emd 
safety 
protection 
of workers 
responding to such an emergency. 
"(E) Public health agencies that are prepared to coordi-
nate health services (including mental health services) 
during and after such emergencies. 
"(F) Participation in communications networks that can 
effectively disseminate relevant information in a timely 
and secure manner to appropriate public and private enti-
ties and to the public. 
"(3) Developing and meiintaining medical countermeasures 
(such as drugs, vaccines and other biological products, medical 
devices, and other supplies) against biological agents and toxins 
that may be involved in such emergencies. 
"(4) Ensuring coordination and minimizing duplication of 
Federal, State, and local planning, preparedness, and response 
activities, including during the investigation of a suspicious 
disease outbreak or other potential public health emergency. 
"(5) Enhancing the readiness of hospitals and other health 
care facilities to respond effectively to such emergencies. 
"(c) REPORTS TO CONGRESS.— 
"(1) IN GENERAL.—Not later than one year after the date Deadline, 
of the enactment of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, and biennially there-
after, the Secretary shall submit to the Committee on Energy 
and Commerce of the House of Representatives, and the Com-
mittee on Health, Education, Labor, and Pensions of the Senate, 
a report concerning progress with respect to the plan under 
116 STAT. 598 
PUBLIC LAW 107-188-^JUNE 12, 2002 
subsection (a), including progress toward achieving the goals 
specified in subsection (b). 
"(2) ADDITIONAL AUTHORITY.—Reports submitted under 
paragraph (1) by the Secretary (other than the first report) 
shall make recommendations concerning— 
"(A) amy additional legislative authority that the Sec-
retary determines is necessary for fully implementing the 
plan under subsection (a), including meeting the goals 
under subsection (b); and 
"(B) any additional legislative authority that the Sec-
retary determines is necessary under section 319 to protect 
the public health in the event of an emergency described 
in section 319(a). 
"(d) RULE OF CONSTRUCTION.—This section may not be con-
strued as expanding or limiting any of the authorities of the Sec-
retary that, on the day before the date of the enactment of the 
Public Health 
Security 
and 
Bioterrorism 
Preparedness 
and 
Response Act of 2002, were in effect with respect to preparing 
for and responding effectively to bioterrorism and other public 
health emergencies.". 
42 use 247d-6 
(b) OTHER REPORTS.— 
note. 
(1) IN GENERAL.—Not later than one year after the date 
Deadline. 
^f ^j^g enactment of this Act, the Secretary of Health and 
Human Services (referred to in this subsection as the "Sec-
retary") shall submit to the Committee on Energy and Com-
merce of the House of Representatives, and the Committee 
on Health, Education, Labor, and Pensions of the Senate, a 
report concerning— 
(A) the recommendations and findings of the National 
Advisory Committee on Children and Terrorism under sec-
tion 319F(c)(2) of the Public Health Service Act; 
(B) the recommendations and findings of the EPIC 
Advisory Committee under section 319F(c)(3) of such Act; 
(C) the characteristics that may render a rureJ commu-
nity uniquely vulnerable to a biological attack, including 
distance, lack of emergency transport, hospital or labora-
tory capacity, lack of integration of Federal or State public 
health networks, workforce deficits, or other relevant 
characteristics; 
(D) the characteristics that may render areas or popu-
lations designated as medically underserved populations 
(as defined in section 330 of such Act) uniquely vulnerable 
to a biological attack, including significant numbers of low-
income or uninsured individuals, lack of affordable and 
accessible health care services, insufficient public and pri-
mary health care resources, lack of integration of Federal 
or State public health networks, workforce deficits, or other 
relevant characteristics; 
(E) the recommendations of the Secretary with respect 
to additional legislative authority that the Secretary deter-
mines is necessary to effectively strengthen rural commu-
nities, or medically underserved populations (as defined 
in section 330 of such Act); and 
(F) the need for and benefits of a National Disaster 
Response Medical Volunteer Service that would be a pri-
vate-sector, community-based rapid response corps of med-
ical volunteers. 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 599 
(2) 
STUDY 
REGARDING 
LOCAL 
EMERGENCY 
RESPONSE 
METHODS.—The Secretary shall conduct a study of effective 
methods for the provision of emergency response services 
through local governments (including through private response 
contractors and volunteers of such governments) in a consistent 
manner in response to acts of bioterrorism or other public 
health emergencies. Not later than 180 days after the date 
of the enactment of this Act, the Secretary shall submit to 
the Committee on Energy and Commerce of the House of Rep-
resentatives, and the Committee on Health, Education, Labor, 
and Pensions of the Senate, a report describing the findings 
of the study. 
SEC. 102. ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY 
PREPAREDNESS; NATIONAL DISASTER MEDICAL SYSTEM. 
(a) IN GENERAL.—Title XXVIII of the Public Health Service 
Act, as added by section 101 of this Act, is amended by adding 
at the end the following subtitle: 
"Subtitle B—Emergency Preparedness and 
Response 
Deadline. 
Reports. 
"SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE 
TO BIOTERRORISM AND OTHER PUBLIC HEALTH EMER-
GENCIES. 
"(a) ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY 
PREPAREDNESS.— 
"(1) IN GENERAL.—There is established within the Depart-
ment of Health and Human Services the position of Assistant 
Secretary for Public Health Emergency Preparedness. The 
President shall appoint an individual to serve in such position. 
Such Assistant Secretary shall report to the Secretary. 
"(2) DUTIES.—Subject to the authority of the Secretary, 
the Assistant Secretary for Public Health Emergency Prepared-
ness shall carry out the following duties with respect to bioter-
rorism and other public health emergencies: 
"(A) Coordinate on behalf of the Secretary— 
"(i) interagency interfaces between the Department 
of Health and Human Services (referred to in this 
paragraph as the 'Department') and other departments, 
agencies, and offices of the United States; and 
"(ii) interfaces between the Department and State 
and local entities with responsibility for emergency 
preparedness. 
"(B) Coordinate the operations of the National Disaster 
Medical System and any other emergency response activi-
ties within the Department of Health and Human Services 
that are related to bioterrorism and other public health 
emergencies. 
"(C) Coordinate the efforts of the Department to bolster 
State and local emergency preparedness for a bioterrorist 
attack or other public health emergency, and evaluate the 
progress of such entities in meeting the benchmarks and 
other outcome measures contained in the national plan 
and in ijneeting the core public health capabilities estab-
lished pursuant to 319A. 
42 use 
300hh-ll. 
Establishment. 
President. 
116 STAT. 600 
PUBLIC LAW 107-188—JUNE 12, 2002 
"(D) Any other duties determined appropriate by the 
Secretary. 
"(b) NATIONAL DISASTER MEDICAL SYSTEM.— 
"(1) IN GENERAL.—^The Secretary shall provide for the oper-
ation in accordance with this section of a system to be known 
as the National Disaster Medical System. The Secretary shall 
designate the Assistant Secretary for Public Health Emergency 
Preparedness as the head of the National Disaster Medical 
System, subject to the authority of the Secretary. 
"(2) FEDERAL AND STATE COLLABORATIVE SYSTEM.— 
"(A) IN GENERAL.—^The National Disaster Medical 
System shall be a coordinated effort by the Federal agencies 
specified in subparagraph (B), working in collaboration 
with the States and other appropriate public or private 
entities, to carry out the purposes described in paragraph 
(3). 
"(B) PARTICIPATING FEDERAL AGENCIES.—^The Federal 
agencies referred to in subparagraph (A) are the Depart-
ment of Health and Human Services, the Federal Emer-
gency Management Agency, the Department of Defense, 
and the Department of Veterans Affairs. 
"(3) PURPOSE OF SYSTEM.— 
"(A) IN GENERAL.—The Secretary may activate the 
National Disaster Medical System to— 
"(i) provide health services, health-related social 
services, other appropriate human services, and appro-
priate auxiliary services to respond to the needs of 
victims of a public health emergency (whether or not 
determined to be a public health emergency under 
section 319); or 
"(ii) be present at locations, and for limited periods 
of time, specified by the Secretary on the basis that 
the Secretary has determined that a location is at 
risk of a public health emergency during the time 
specified. 
"(B) ONGOING ACTIVITIES.—The National Disaster Med-
ical System shall carry out such ongoing activities as may 
be necessary to prepare for the provision of services 
described in subparagraph (A) in the event that the Sec-
retary activates the National Disaster Medical System for 
such purposes. 
"(C) TEST FOR MOBILIZATION OF SYSTEM.—During the 
one-year period beginning on the date of the enactment 
of the Public Health Security and Bioterrorism Prepared-
ness and Response Act of 2002, the Secretary shall conduct 
an exercise to test the capability and timeliness of the 
National Disaster Medical System to mobilize and other-
wise respond effectively to a bioterrorist attack or other 
public health 
emergency 
that 
affects 
two or more 
geographic locations concurrently. Thereafter, the Secretary 
may periodically conduct such exercises regarding the 
National Disaster Medical System as the Secretary deter-
mines to be appropriate. 
"(c) CRITERL^.— 
"(1) IN GENERAL.—The Secretary shall establish criteria 
for the operation of the National Disaster Medical System. 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 601 
"(2) PARTICIPATION AGREEMENTS FOR NON-FEDERAL ENTI-
TIES.—In carrying out paragraph (1), the Secretary shall estab-
lish criteria regarding the participation of States and private 
entities in the National Disaster Medical System, including 
criteria regarding agreements for such participation. The cri-
teria shall include the following: 
"(A) Provisions relating to the custody and use of Fed-
eral personal property by such entities, which may in the 
discretion of the Secretary include authorizing the custody 
and use of such property to respond to emergency situations 
for which the National Disaster Medical System has not 
been activated by the Secretary pursuant to subsection 
(b)(3)(A). Any such custody and use of Federal personal 
property shall be on a reimbursable basis. 
"(B) Provisions relating to circumstances in which an 
individual or entity has agreements with both the National 
Disaster Medical System and another entity regarding the 
provision of emergency services by the individual. Such 
provisions shall address the issue of priorities among the 
agreements involved. 
"(d) INTERMITTENT DISASTER-RESPONSE PERSONNEL.— 
"(1) IN GENERAL.—For the purpose of assisting the National 
Disaster Medical System in carrying out duties under this 
section, the Secretary may appoint individuals to serve as inter-
mittent personnel of such System in accordance with applicable 
civil service laws and regulations. 
"(2) LIABILITY.—For purposes of section 224(a) and the 
remedies described in such section, an individual appointed 
under paragraph (1) shall, while acting within the scope of 
such appointment, be considered to be an employee of the 
Public Health Service performing medical, surgical, dental, or 
related functions. With respect to the participation of individ-
uals appointed under paragraph (1) in training programs 
authorized by the Assistant Secretary for Public Health Emer-
gency Preparedness or a comparable official of any Federal 
agency specified in subsection (b)(2)(B), acts of individuals so 
appointed that are within the scope of such participation shall 
be considered within the scope of the appointment under para-
graph (1) (regardless of whether the individuals receive com-
pensation for such participation). 
"(e) CERTAIN EMPLOYMENT ISSUES REGARDING INTERMITTENT 
APPOINTMENTS.— 
"(1) 
INTERMITTENT 
DISASTER-RESPONSE 
APPOINTEE.—For 
purposes of this subsection, the term 'intermittent disaster-
response appointee' means an individual appointed by the Sec-
retary under subsection (d). 
"(2) COMPENSATION FOR WORK INJURIES.—An intermittent 
disaster-response appointee shall, while acting in the scope 
of such appointment, be considered to be an employee of the 
Public Health Service performing medical, surgical, dental, or 
related functions, and an injury sustained by such an individual 
shall be deemed 'in the performance of duty', for purposes 
of chapter 81 of title 5, United States Code, pertaining to 
compensation for work injuries. With respect to the participa-
tion of individuals appointed under subsection (d) in training 
programs authorized by the Assistant Secretary for Public 
Health Emergency Preparedness or a comparable official of 
116 STAT. 602 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
any Federal agency specified in subsection (b)(2XB), injuries 
sustained by such an individual, while acting within the scope 
of such participation, also shall be deemed 'in the performance 
of duty' for purposes of chapter 81 of title 5, United States 
Code (regardless of whether the individuals receive compensa-
tion for such participation). In the event of an injury to such 
an intermittent disaster-response appointee, the Secretary of 
Labor shall be responsible for making determinations as to 
whether the claimant is entitled to compensation or other bene-
fits in accordance with chapter 81 of title 5, United States 
Code. 
"(3) EMPLOYMENT AND REEMPLOYMENT RIGHTS.— 
"(A) IN GENERAL.—Service as an intermittent disaster-
response appointee when the Secretary activates the 
National Disaster Medical System or when the individual 
participates in a training program authorized by the Assist-
ant Secretary for Public Health Emergency Preparedness 
or a comparable official of any Federal agency specified 
in subsection (b)(2)(B) shall be deemed 'service in the uni-
formed services' for purposes of chapter 43 of title 38, 
United 
States 
Code, pertaining to emplo5mient 
and 
reemployment rights of individuals who have performed 
service in the uniformed services (regardless of whether 
the individual receives compensation for such participa-
tion). All rights and obligations of such persons and proce-
dures for assistance, enforcement, and investigation shall 
be as provided for in chapter 43 of title 38, United States 
Code. 
"(B) NOTICE OF ABSENCE FROM POSITION OF EMPLOY-
MENT.—Preclusion of giving notice of service by necessity 
of Service as an intermittent disaster-response appointee 
when the Secretary activates the National Disaster Medical 
System shall be deemed preclusion by 'military necessity' 
for purposes of section 4312(b) of title 38, United States 
Code, pertaining to giving notice of absence from a position 
of employment. A determination of such necessity shall 
be made by the Secretary, in consultation with the Sec-
retary of Defense, and shall not be subject to judicial 
review. 
"(4) 
LIMITATION.—^An 
intermittent 
disaster-response 
appointee shall not be deemed an employee of the Department 
of Health and Human Services for purposes other than those 
specifically set forth in this section. 
"(f) RULE OF CONSTRUCTION REGARDING USE OF COMMISSIONED 
CORPS.—If the Secretary assigns commissioned officers of the Reg-
ular or Reserve Corps to serve with the National Disaster Medical 
System, such assignments do not affect the terms and conditions 
of their appointments as commissioned officers of the Regular or 
Reserve Corps, respectively (including with respect to pay and 
allowances, retirement, benefits, rights, privileges, and immunities). 
"(g) DEFINITION.—^For purposes of this section, the term 'auxil-
iary services' includes mortuary services, veterinary services, and 
other services that are determined by the Secretary to be appro-
priate with respect to the needs referred to in subsection (b)(3)(A). 
"(h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
providing for the Assistant Secretary for Public Health Emergency 
Preparedness and the operations of the National Disaster Medical 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 603 
System, other than purposes for which amounts in the PubUc Health 
Emergency Fund under section 319 are available, there are author-
ized to be appropriated such sums as may be necessary for each 
of the fiscal years 2002 through 2006.". 
(b) SENSE OF CONGRESS REGARDING RESOURCES OF NATIONAL 
DiSi^TER MEDICAL SYSTEM.—It is the sense of the Congress that 
the Secretary of Health and Human Services should provide suffi-
cient resources to entities tasked to carry out the duties of the 
National Disaster Medical System for reimbursement of expenses, 
operations, purchase and maintenance of equipment, training, and 
other funds expended in furtherance of the National Disaster Med-
ical System. 
SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL 
AND PREVENTION. 
Section 319D of the Public Health Service Act (42 U.S.C. 247d-
4) is amended to read as follows: 
"SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND 
PREVENTION. 
"(a) FACILITIES; CAPACITIES.— 
"(1) FINDINGS.—Congress finds that the Centers for Disease 
Control and Prevention has an essential role in defending 
against and combatting public health threats and requires 
secure and modem facilities, and expanded and improved 
capabilities related to bioterrorism and other public health 
emergencies, sufficient to enable such Centers to conduct this 
important mission. 
"(2) FACILITIES.— 
"(A) IN GENERAL.—The Director of the Centers for Dis-
ease Control and Prevention may design, construct, and 
equip new facilities, renovate existing facilities (including 
laboratories, 
laboratory 
support 
buildings, 
scientific 
communication facilities, transshipment complexes, secured 
and isolated parking structures, office buildings, and other 
facilities and infrastructure), and upgrade security of such 
facilities, in order to better conduct the capacities described 
in section 319A, and for supporting public health activities. 
"(B) MULTIYEAR CONTRACTING AUTHORITY.—For 
a n y 
project of designing, constructing, equipping, or renovating 
any facility under subparagraph (A), the Director of the 
Centers for Disease Control and Prevention may enter 
into a single contract or related contracts that collectively 
include the full scope of the project, and the solicitation 
and contract shall contain the clause 'availability of funds' 
found at section 52.232-18 of title 48, Code of Federal 
Regulations. 
"(3) IMPROVING THE CAPACITIES OF THE CENTERS FOR DIS-
EASE CONTROL AND PREVENTION.—The Secretary, taking into 
account evaluations under section 319B(a), shall expand, 
enhance, and improve the capabilities of the Centers for Disease 
Control and Prevention relating to preparedness for and 
responding effectively to bioterrorism and other public health 
emergencies. Activities that may be carried out under the pre-
ceding sentence include— 
"(A) expanding or enhancing the training of personnel; 
"(B) improving communications facilities and networks, 
including delivery of necessary information to rural areas; 
116 STAT. 604 
PUBLIC LAW 107-188—JUNE 12, 2002 
"(C) improving capabilities for public health surveil-
lance and reporting activities, taking into account the 
integrated system or systems of public healtli alert commu-
nications and surveillance networks under subsection (b); 
and 
"(D) improving laboratory facilities related to bioter-
rorism and other public health emergencies, including 
increasing the security of such facilities. 
"(b) 
NATIONAL COMMUNICATIONS AND SURVEILLANCE NET-
WORKS.— 
"(1) IN GENERAL.—^The Secretary, directly or through 
awards of grants, contracts, or cooperative agreements, shall 
provide for the establishment of an integrated system or sys-
tems of public health alert communications and surveillance 
networks between and among— 
"(A) Federal, State, and local public health officials; 
"(B) public and private health-related laboratories, hos-
pitals, and other hesilth care facilities; and 
"(C) any other entities determined appropriate by the 
Secretary. 
"(2) REQUIREMENTS.—The Secretary shall ensure that net-
works under paragraph (1) allow for the timely sharing and 
discussion, in a secure manner, of essential information con-
cerning bioterrorism or another public health emergency, or 
recommended methods for responding to such an attack or 
emergency. 
Deadline. 
"(3) STANDARDS.—^Not later than One year after the date 
of the enactment of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, the Secretary, in 
cooperation with health care providers and State and local 
public health officials, shall establish any additional technical 
and reporting standards (including standards for interoper-
ability) for networks under paragraph (1). 
"(c) AUTHORIZATION OF APPROPRIATIONS.— 
"(1) FACILITIES; CAPACITIES.— 
"(A) FACILITIES.—^For the purpose of carrying out sub-
section (a)(2), there are authorized to be appropriated 
$300,000,000 for each of the fiscal years 2002 and 2003, 
and such sums as may be necessary for each of the fiscal 
years 2004 through 2006. 
"(B) MISSION; IMPROVING CAPACITIES.—For the pur-
poses of achieving the mission of the Centers for Disease 
Control and Prevention described in subsection (a)(1), for 
carrying out subsection (a)(3), for better conducting the 
capacities described in section 319A, and for supporting 
public health activities, there are authorized to be appro-
priated such sums as may be necessary for each of the 
fiscal years 2002 through 2006. 
"(2) NATIONAL COMMUNICATIONS AND SURVEILLANCE NET-
WORKS.—^For the purpose of carrying out subsection (b), there 
are authorized to be appropriated such sums as may be nec-
essary for each of the fiscal years 2002 through 2006.". 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 605 
SEC. 
104. ADVISORY COMMITTEES AND COMMUNICATIONS; STUDY 
REGARDING COMMUNICATIONS ABILITIES OF PUBLIC 
HEALTH AGENCIES. 
(a) IN GENERAL.—Section 319F of the Public Health Service 
Act (42 U.S.C. 247d-6) is amended— 
(1) by striking subsections (b) and (i); 
(2) by redesignating subsections (c) through (h) as sub-
sections (e) through (j), respectively; and 
(3) by inserting after subsection (a) the following sub-
sections: 
"(b) ADVICE TO THE FEDERAL GOVERNMENT.— 
"(1) REQUIRED ADVISORY COMMITTEES.—^In coordination 
with the working group under subsection (a), the Secretary 
shall establish advisory committees in accordance with para-
graphs (2) and (3) to provide expert recommendations to assist 
such working groups in carrying out their respective respon-
sibilities under subsections (a) and (b). 
"(2) NATIONAL ADVISORY COMMITTEE ON CHILDREN AND TER-
RORISM.— 
"(A) IN GENERAL.—^For purposes of paragraph (1), the 
Secretary shall establish an advisory committee to be 
known as the National Advisory Committee on Children 
and Terrorism (referred to in this paragraph as the 
'Advisory Committee'). 
"(B) DUTIES.—^The Advisory Committee shall provide 
recommendations regarding— 
"(i) the preparedness of the health care (including 
mental health care) system to respond to bioterrorism 
as it relates to children; 
"(ii) needed changes to the health care and emer-
gency medical service systems and emergency medical 
services protocols to meet the special needs of children; 
and 
"(iii) changes, if necessary, to the national stockpile 
under section 121 of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 
to meet the emergency health security of children. 
"(C) COMPOSITION.—^The Advisory Committee shall be 
composed of such Federal officials as may be appropriate 
to address the special needs of the diverse population 
groups of children, and child health experts on infectious 
disease, environmental health, toxicology, and other rel-
evant professional disciplines. 
"(D) TERMINATION.—The Advisory Committee termi-
nates one year after the date of the enactment of the 
Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002. 
"(3) 
EMERGENCY PUBLIC INFORMATION AND COMMUNICA-
TIONS ADVISORY COMMITTEE.— 
"(A) IN GENERAL.—For purposes of paragraph (1), the 
Secretary shall i establish an advisory committee to be 
known as the Emergency Public Information and Commu-
nications Advisory Committee (referred to in this para-
graph as the 'EPIC Advisory Committee'). 
"(B) DUTIES.—The EPIC Advisory Committee shall 
make recommendations to the Secretary and the working 
group under subsection (a) and report on appropriate ways 
Establishment. 
Establishment. 
116 STAT. 606 
PUBLIC LAW 107-188-JUNE 12, 2002 
42 use 247d-6 
note. 
42 use 247d-6. 
to communicate public health information regarding bioter-
rorism and other public health emergencies to the public. 
"(C) COMPOSITION.—^The EPIC Advisory Committee 
shall be composed of individuals representing a diverse 
group of experts in public health, medicine, communica-
tions, behavioral psychology, and other areas determined 
appropriate by the Secretary. 
"(D) DISSEMINATION.—The Secretary shall review the 
recommendations of the EPIC Advisory Committee and 
ensure that appropriate information is disseminated to the 
public. 
"(E) TERMINATION.—^The EPIC Advisory Committee 
terminates one year after the date of the enactment of 
Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002. 
"(c) 
STRATEGY 
FOR 
CoMMUNieATiON 
OF 
INFORMATION 
REGARDING BIOTERRORISM AND OTHER PUBLIC HEALTH EMER-
GENCIES.—In coordination with working group under subsection 
(a), the Secretary shall develop a strategy for effectively commu-
nicating information regarding bioterrorism and other public health 
emergencies, and shall develop means by which to communicate 
such information. The Secretary may carry out the preceding sen-
tence directly or through grants, contracts, or cooperative agree-
ments. 
"(d) RECOMMENDATION OF CONGRESS REGARDING OFFICIAL FED-
ERAL INTERNET SITE ON BIOTERRORISM.—^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 information rel-
evant to diverse populations (including messages directed at the 
general public and such relevant groups as medical personnel, 
public safety workers, and agricultural workers) £ind links to appro-
priate State and local government sites.". 
(b) STUDY REGARDING COMMUNICATIONS ABILITIES OF PUBLIC 
HEALTH AGENCIES.—The Secretary of Health and Human Services, 
in consultation with the Federal Communications Commission, the 
National Telecommunications and Information Administration, and 
other appropriate Federal agencies, shall conduct a study to deter-
mine whether local public health entities have the ability to main-
tain communications in the event of a bioterrorist attack or other 
public health emergency. The study shall examine whether 
redundancies are required in the telecommunications system, 
particularly with respect to mobile communications, for public 
health entities to maintain systems operability and connectivity 
during such emergencies. The study shall also include recommenda-
tions to industry and public health entities about how to implement 
such redundancies if necessary. 
SEC. 
105. EDUCATION OF HEALTH CARE PERSONNEL; TRAINING 
REGARDING PEDIATRIC ISSUES. 
Section 319F(g) of the Public Health Service Act, as redesig-
nated by section 104(a)(2) of this Act, is amended to read as follows: 
"(g) EDUCATION; TRAINING REGARDING PEDIATRIC ISSUES.— 
"(1) MATERL\LS; CORE CURRICULUM.—The Secretary, in 
collaboration with members of the working group described 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
116 STAT. 607 
in subsection (b), and professional organizations and societies, 
shall— 
"(A) develop materials for teaching the elements of 
a core curriculum for the recognition and identification 
of potential bioweapons and other agents that may create 
a public health emergency, and for the care of victims 
of such emergencies, recognizing the special needs of chil-
dren and other vulnerable populations, to public health 
officials, medical professionals, emergency physicians and 
other emergency department staff, laboratory personnel, 
and other personnel working in health care facilities 
(including poison control centers); 
"(B) develop a core curriculum and materials for 
community-wide planning by State and local governments, 
hospitals and other health care facilities, emergency 
response units, and appropriate public and private sector 
entities to respond to a bioterrorist attack or other public 
health emergency; 
"(C) develop materials for proficiency testing of labora-
tory and other public health personnel for the recognition 
and identification of potential bioweapons and other agents 
that may create a public health emergency; and 
"(D) provide for dissemination and teaching of the 
materials described in subparagraphs (A) through (C) by 
appropriate means, which may include telemedicine, long-
distance learning, or other such means. 
"(2) CERTAIN ENTITIES.—The entities through which edu-
cation and training activities described in paragraph (1) may 
be carried out include Public Health Preparedness Centers, 
the Public Health Service's Noble Training Center, the 
Emerging 
Infections 
Program, the Epidemic 
Intelligence 
Service, the Public Health Leadership Institute, multi-State, 
multi-institutional consortia, other appropriate educational 
entities, professional organizations and societies, private accred-
iting organizations, and other nonprofit institutions or entities 
meeting criteria established by the Secretary. 
"(3) GRANTS AND CONTRACTS.—In carrying out paragraph 
(1), the Secretary may carry out activities directly and through 
the award of grants and contracts, and may enter into inter-
agency cooperative agreements with other Federal agencies. 
"(4) 
HEALTH-RELATED 
ASSISTANCE 
FOR 
EMERGENCY 
RESPONSE PERSONNEL TRAINING.—The Secretary, in consulta-
tion with the Attorney General and the Director of the Federal 
Emergency Management Agency, may provide technical assist-
ance with respect to health-related aspects of emergency 
response personnel training carried out by the Department 
of Justice and the Federal Emergency Management Agency.". 
SEC. 1
0
6
. 
GRANTS REGARDING SHORTAGES OF 
CERTAIN HEALTH 
PROFESSIONALS. 
Part B of title III of the Public Health Service Act (42 U.S.C. 
243 et seq.) is amended by inserting after section 319G the following 
section: 
"SEC. 319H. GRANTS REGARDING TRAINING AND EDUCATION OF CER- 
42 USC 247d-7a. 
TAIN HEALTH PROFESSIONALS. 
"(a) IN GENERAL.—The Secretary may make awards of grants 
and cooperative agreements to appropriate public and nonprofit 
116 STAT. 608 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
private health or educational entities, including health professions 
schools and programs as defined in section 799B, for the purpose 
of providing low-interest loans, partial scholarships, partial fellow-
ships, revolving loan funds, or other cost-sharing forms of assistance 
for the education and training of individuals in any category of 
health professions for which there is a shortage that the Secretary 
determines should be alleviated in order to prepare for or respond 
effectively to bioterrorism and other public health emergencies. 
"(b) AUTHORITY REGARDING NON-FEDERAL CONTRIBUTIONS.— 
The Secretary may require as a condition of an award under sub-
section (a) that a grantee under such subsection provide non-Federal 
contributions toward the purpose described in such subsection. 
"(c) AUTHORIZATION OF APPROPRIATIONS.—^For the purpose of 
carrying out this section, there are authorized to be appropriated 
such sums as may be necessary for each of the fiscal years 2002 
through 2006.". 
SEC. 107. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF 
HEALTH PROFESSIONS VOLUNTEERS. 
Part B of title III of the Public Health Service Act, as amended 
by section 106 of this Act, is amended by inserting after section 
319H the following section: 
42 use 247d-7b. 
"SEC. 319L EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF 
HEALTH PROFESSIONS VOLUNTEERS. 
"(a) IN GENERAL.—^The Secretary shall, directly or through an 
award of a grant, contract, or cooperative agreement, establish 
and maintain a system for the advance registration of health profes-
sionals for the purpose of verifying the credentials, licenses, accredi-
tations, and hospital privileges of such professionals when, during 
public health emergencies, the professionals volunteer to provide 
health services (referred to in this section as the 'verification 
system'). In carrying out the preceding sentence, the Secretary 
shall provide for an electronic database for the verification system. 
"(b) CERTAIN CRITERLV.—The Secretary shall establish provi-
sions regarding the promptness and efficiency of the system in 
collecting, storing, updating, and disseminating information on the 
credentials, licenses, accreditations, and hospital privileges of volun-
teers described in subsection (a). 
"(c) OTHER ASSISTANCE.—^The Secretary may make grants and 
provide technical assistance to States and other public or nonprofit 
private entities for activities relating to the verification system 
developed under subsection (a). 
"(d) 
COORDINATION 
AMONG 
STATES.—The 
Secretary 
may 
encourage each State to provide legal authority during a public 
health emergency for health professionals authorized in another 
State to provide certain health services to provide such health 
services in the State. 
"(e) RULE OF CONSTRUCTION.—^This section may not be con-
strued as authorizing the Secretary to issue requirements regarding 
the provision by the States of credentials, licenses, accreditations, 
or hospital privileges. 
"(f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
$2,000,000 for fiscal year 2002, and such sums as may be necessary 
for each of the fiscal years 2003 through 2006.". 
PUBLIC LAW 107-188-^JUNE 12, 2002 
116 STAT. 609 
SEC. 108. WORKING GROUP. 
Section 319F of the Public Health Service Act, as amended 
by section 104(a), is amended by striking subsection (a) and 
42 USC 247d-6. 
inserting the following: 
"(a) WORKING GROUP ON BIOTERRORISM AND OTHER PUBLIC 
HEALTH EMERGENCIES.— 
"(1) IN GENERAL.—The Secretary, in coordination with the 
Secretary of Agriculture, the Attorney General, the Director 
of Central Intelligence, the Secretary of Defense, the Secretary 
of Energy, the Administrator of the Environmental Protection 
Agency, the Director of the Federal Emergency Management 
Agency, the Secretary of Labor, the Secretary of Veterans 
Affairs, and with other similar Federal officials as determined 
appropriate, shall establish a working group on the prevention, 
preparedness, and response to bioterrorism and other public 
health emergencies. Such joint working group, or subcommit-
tees thereof, shall meet periodically for the purpose of consulta-
tion on, assisting in, and making recommendations on— 
"(A) responding to a bioterrorist attack, including the 
provision of appropriate safety and health training and 
protective measures for medical, emergency service, and 
other personnel responding to such attacks; 
"(B) prioritizing countermeasures required to treat, 
prevent, or identify exposure to a biological agent or toxin 
pursuant to section 35lA; 
"(C) facilitation of the awarding of grants, contracts, 
or cooperative agreements for the development, manufac-
ture, distribution, supply-chain management, and purchase 
of priority countermeasures; 
"(D) research on pathogens likely to be used in a 
biological threat or attack on the civilian population; 
"(E) development of shared standards for equipment 
to detect Eind to protect against biological agents and toxins; 
"(F) assessment of the priorities for and enhancement 
of the preparedness of public health institutions, providers 
of medical care, and other emergency service personnel 
(including firefighters) to detect, diagnose, and respond 
(including mental health response) to a biological threat 
or attack; 
"(G) in the recognition that medical and public health 
professionals are likely to provide much of the first response 
to such an attack, development and enhancement of 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— 
"(i) local firefighters, ambulance personnel, police 
and public seciuity officers, or other emergency 
response personnel (including private response contrac-
tors); and 
"(ii) hospitals, primary CEire facilities, and public 
health agencies; 
"(H) development of strategies for Federal, State, and 
local agencies to communicate information to the public 
regarding biologicgJ threats or attacks; 
116 STAT. 610 
PUBLIC LAW 107-188—JUNE 12, 2002 
"(I) ensuring that the activities under this subsection 
address the health security needs of children and other 
vulnerable populations; 
"(J) strategies for decontaminating facilities contami-
nated as a result of a biological attack, including appro-
priate protections for the safety of workers conducting such 
activities; 
"(K) subject to compliance with other provisions of 
Federal law, clarifying the responsibilities among Federal 
officials for the investigation of suspicious outbreaks of 
disease and other potential public health emergencies, and 
for related revisions of the interagency plan known as 
the Federal response plan; and 
"(L) in consultation with the National Highway Traffic 
Safety Administration and the U.S. Fire Administration, 
ways to enhance coordination among Federal agencies 
involved with State, local, and community based emergency 
medical services, including issuing a report that— 
"(i) identifies needs of community-based emergency 
medical services; and 
"(ii) identifies ways to streamline and enhance the 
process through which Federal 
agencies 
support 
community-based emergency medical services. 
"(2) CONSULTATION WITH EXPERTS.—In carrying out sub-
paragraphs (B) and (C) of paragraph (1), the working group 
under such paragraph shall consult with the pharmaceutical, 
biotechnology, and medical device industries, and other appro-
priate experts. 
"(3) U S E OF SUBCOMMITTEES REGARDING CONSULTATION 
REQUIREMENTS.—^With respect to a requirement under law that 
the working group under paragraph (1) be consulted on a 
matter, the working group may designate an appropriate sub-
committee of the working group to engage in the consultation. 
"(4) DISCRETION IN EXERCISE OF DUTIES.—^Determinations 
made by the working group under paragraph (1) with respect 
to carrying out duties under such paragraph are matters com-
mitted to agency discretion for purposes of section 701(a) of 
title 5, Unites States Code. 
"(5) RULE OF CONSTRUCTION.—This subsection may not be 
construed as establishing new regulatory authority for any 
of the officials specified in paragraph (1), or as having any 
legal effect on any other provision of law, including the respon-
sibilities and authorities of the Environmental Protection 
Agency.". 
SEC. 109. ANTIMICROBIAL RESISTANCE. 
Section 319E of the Public Health Service Act (42 U.S.C. 247d-
5) is amended— 
(1) in subsection (b)— 
(A) by striking "shall conduct and support" and 
inserting "shall directly or through awards of grants or 
cooperative agreements to public or private entities provide 
for the conduct of; and 
(B) by amending paragraph (4) to read as follows: 
"(4) the sequencing of the genomes, or other DNA analysis, 
or other comparative analysis, of priority pathogens (as deter-
mined by the Director of the National Institutes of Health 
PUBLIC LAW 107-18&-JUNE 12, 2002 
116 STAT. 611 
in consultation with the task force estabUshed under subsection 
(a)), in collaboration and coordination with the activities of 
the Department of Defense and the Joint Genome Institute 
of the Department of Energy; and"; 
(2) in subsection (eX2), by inserting after "societies," the 
following: "schools or programs that train medical laboratory 
personnel,"; and 
(3) in subsection (g), by striking "and such sums" and 
all that follows and inserting the following: "$25,000,000 for 
each of the fiscal years 2002 and 2003, and such sums as 
may be necessary for each of the fiscal years 2004 through 
2006.". 
SEC. 110. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS. 
Part B of title III of the Public Health Service Act, as amended 
by section 107 of this Act, is amended by inserting after section 
3191 the following section: 
"SEC. 319J. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS. 
"(a) IN GENERAL.—Upon the request of a recipient of an award 
imder any of sections 319 through 3191 or section 319K, the Sec-
retary may, subject to subsection (b), provide supplies, equipment, 
£Uid services for the purpose of aiding the recipient in canying 
out the purposes for which the award is made and, for such pur-
poses, may det£ul to the recipient any officer or employee of the 
Department of Health and Human Services. 
"(b) CORRESPONDING REDUCTION IN PAYMENTS.—-With respect 
to a request described in subsection (a), the Secretary shall reduce 
the amount of payments under the award involved by an amount 
equal to the costs of detailing personnel euid the fair market value 
of any supplies, equipment, or services provided by the Secretary. 
The Secretary shall, for the pa3m[ient of expenses incurred in com-
plying with such request, expend the amoiuits withheld.". 
SEC. 111. ADDITIONAL AMENDMENTS. 
Part B of title III of the PubUc Health Service Act (42 U.S.C. 
243 et seq.) is amended— 
(1) in section 319A(a)(l), by striking "10 years" and 
inserting "five yesurs"; 
(2) in section 319B(a), in the first sentence, by striking 
"10 years" and inserting "five years"; and 
(3) in section 391F(e)(2), as redesignated by section 
104(a)(2) of this Act— 
(A) by striking "or" after "clinic,"; and 
(B) by inserting before the period following: ", profes-
sionsd organization or society, school or progreun that trains 
medical laboratory personnel, private accrediting orgEuiiza-
tion, or other nonprofit private institution or entity meeting 
criteria established by the Secretary". 
42 use 247d-7c. 
42 use 247d-l. 
42 use 247d-2. 
42 use 247d-6. 
Subtitle B—Strategic National Stockpile; 
Development of Priority Countermeasures 
SEC. 121. STRATEGIC NATIONAL STOCKPILE. 
(a) STRATEGIC NATIONAL STOCKPILE.— 
42 use 
300hh-12. 
116 STAT. 612 
PUBLIC LAW 107-188—JUNE 12, 2002 
(1) IN GENERAL.—^The Secretary of Health and Human 
Services (referred to in this section as the "Secretary"), in 
coordination with the Secretary of Veterans Affairs, shall main-
tain a stockpile or stockpiles of drugs, vaccines and other 
biological products, medical devices, and other supplies in such 
numbers, types, and amounts as are determined by the Sec-
retary to be appropriate and practicable, taking into account 
other available sources, to provide for the emergency health 
security of the United States, including the emergency health 
security of children and other vulnerable populations, in the 
event of a bioterrorist attack or other public health emergency. 
(2) PROCEDURES.—The Secretary, in managing the stockpile 
luider paragraph (1), shall— 
(A) consult with the working group under section 
319F(a) of the Public Health Service Act; 
(B) ensure that adequate procedures are followed with 
respect to such stockpile for inventory management and 
accounting, and for the physical security of the stockpile; 
(C) in consultation with Federal, State, and local offi-
cials, take into consideration the timing and location of 
special events; 
(D) review and revise, as appropriate, the contents 
of the stockpile on a regular basis to ensure that emerging 
threats, advanced technologies, and new countermeasures 
are adequately considered; 
(E) devise plans for the effective and timely supply-
chain management of the stockpile, in consultation with 
appropriate Federal, State and local agencies, and the 
public and private health care infrastructure; and 
(F) ensure the adequate physical security of the stock-
pile. 
(b) SMALLPOX VACCINE DEVELOPMENT.— 
Contracts. 
(1) IN GENERAL.—^The Secretary shall award contracts, 
enter into cooperative agreements, or carry out such other 
activities as may reasonably be required in order to ensure 
that the stockpile under subsection (a) includes an amount 
of vaccine against smallpox as determined by the Secretary 
to be sufficient to meet the health security needs of the United 
States. 
(2) RULE OF CONSTRUCTION.—Nothing in this section shall 
be construed to limit the private distribution, purchase, or 
sale of vaccines from sources other than the stockpile described 
in subsection (a). 
(c) DISCLOSURES.—^No Federal agency shall disclose under sec-
tion 552, United States Code, any information identifying the loca-
tion at which materials in the stockpile under subsection (a) are 
stored. 
(d) DEFINITION.—^For purposes of subsection (a), the term 
"stockpile" includes— 
(1) a physical accumulation (at one or more locations) of 
the supplies described in subsection (a); or 
(2) a contractual agreement between the Secretary and 
a vendor or vendors imder which such vendor or vendors agree 
to provide to the Secretary supplies described in subsection 
(a). 
(e) AUTHORIZATION OF APPROPRL\TIONS.— 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 613 
(1) STRATEGIC NATIONAL STOCKPILE.—For the purpose of 
carrying out subsection (a), there are authorized to be appro-
priated $640,000,000 for fiscal year 2002, and such sums as 
may be necessary for each of fiscal years 2003 through 2006. 
(2) SMALLPOX VACCINE DEVELOPMENT.—For the purpose of 
carrying out subsection (b), there are authorized to be appro-
priated $509,000,000 for fiscal year 2002, and such sums as 
may be necessary for each of fiscal years 2003 through 2006. 
SEC. 
122. ACCELERATED 
APPROVAL 
OF 
PRIORITY 
COUNTER- 
21USC 356-1. 
MEASURES. 
(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 review priority pursuant 
to section 515(d)(5) of such Act (21 U.S.C. 360e(d)(5)). Such a 
designation may he 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(aX3) 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) U S E OF ANIMAL TRIALS.^A drug for which approval is 
sought under section 505(b) 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 
pursuant to section 123 may be designated as a fast track product 
for purposes of this section. 
(c) PRIORITY REVIEW OF DRUGS AND BIOLOGICAL PRODUCTS.— 
A priority countermeasure that is a drug or biological product 
shall be considered a priority drug or biological product for purposes 
of performance goals for priority drugs or biological products agreed 
to by the Commissioner of Food and Drugs. 
(d) DEFINITIONS.—^For purposes of this title: 
(1) The term "priority countermeasure" has the meaning 
given such term in section 319F(h)(4) of the Public Health 
Service Act. 
(2) The term "priority drugs or biological products" means 
a drug or biological product that is the subject of a drug 
or biologies application referred to in section 101(4) of the 
Food and Drug Administration Modernization Act of 1997. 
SEC 123. ISSUANCE OF RULE ON ANIMAL TRIALS. 
Not later than 90 days after the date of the enactment of Deadline, 
this Act, the Secretary of Health and Human Services shall complete 
the process of rulemaking that was commenced under authority 
of section 505 of the Federal Food, Drug, and Cosmetic Act and 
section 351 of the Public Health Service Act with the issuance 
of the proposed rule entitled "New Drug and Biological Drug Prod-
ucts; Evidence Needed to Demonstrate Efficacy of New Drugs for 
Use Against Lethal or Permanently Disabling Toxic Substances 
When Efficacy Studies in Humans Ethically Cannot be Conducted" 
published in the Federal Register on October 5, 1999 (64 Fed. 
Reg. 53960), and shall promulgate a final rule. 
116 STAT. 614 
PUBLIC LAW 107-188-JUNE 12, 2002 
SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMDENT AND 
PRODUCTION. 
Part B of title III of the Public Health Service Act, as amended 
by section 110 of this Act, is simended by inserting after section 
319J the following section: 
42 use 247d-7d. "SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND 
PRODUCTION. 
"(a) IN GENERAL.—The Secretary, in consultation with the 
Attorney General and the Secretary of Defense, may provide tech-
nical or other assistance to provide security to persons or facilities 
that conduct development, production, distribution, or storage of 
priority countermeasures (as defined in section 319F(h)(4)). 
"(b) GUIDELINES.—The Secretary may develop guidelines to 
enable entities eligible to receive assistance under subsection (a) 
to secure their facilities against potential terrorist attack.". 
SEC. 
125. ACCELERATED 
COUNTERMEASURE 
RESEARCH AND 
DEVELOPMENT. 
Section 319F(h) of the Public Health Service Act, as redesig-
42 use 247d-6. 
nated by section 104(a)(2) of this Act, is amended to read as follows: 
"(h) ACCELERATED RESEARCH AND DEVELOPMENT ON PRIORITY 
PATHOGENS AND COUNTERMEASURES.— 
"(1) IN GENERAL.—^With respect to pathogens of potential 
use in a bioterrorist attack, and other agents that may cause 
a public health emergency, the Secretsiry, taking into consider-
ation any recommendations of the working group under sub-
section (a), shall conduct, and award grants, contracts, or 
cooperative agreements for, research, investigations, experi-
ments, demonstrations, £ind studies in the health sciences 
relating to— 
"(A) the epidemiology and pathogenesis of such patho-
gens; 
"(B) the sequencing of the genomes, or other DNA 
analysis, or other comparative sinalysis, of priority patho-
gens (as determined by the Director of the National 
Institutes of Health in consultation with the working group 
established in subsection (a)), in collaboration and coordina-
tion with the activities of the Department of Defense and 
the Joint G«nome Institute of the Department of Energy; 
"(C) the development of priority countermeasures; and 
"(D) other relevant areas of research; 
with consideration given to the needs of children £ind other 
vulnerable populations. 
"(2) PRIORITY.—The Secretary shadl give priority under this 
section to the funding of research and other studies related 
to priority countermeasures. 
"(3) ROLE OF DEPARTMENT OF VETERANS AFFAIRS.—In car-
i 
rying out paragraph (1), the Secretary shall consider using 
^ 
the biomedical research and development capabilities of the 
Department of Veterans Affeiirs, in conjunction with that 
Department's affiliations with health-professions universities. 
When advantageous to the Government in furtherance of the 
purposes of such paragraph, the Secretary may enter into 
cooperative agreements with the Secretary of Veterans Affairs 
to achieve such purposes. 
PUBLIC LAW 107-188-^JUNE 12, 2002 
116 STAT. 615 
"(4) PRIORITY COUNTERMEASURES.—For purposes of this sec-
tion, the term 'priority countermeasure' means a drug, biologicgJ 
product, device, vaccine, vaccine adjuvant, antiviral, or diag-
nostic test that the Secretary determines to be— 
"(A) a priority to treat, identify, or prevent infection 
by a biological agent or toxin listed pursuant to section 
351A(a)(l), or harm from any other agent that may cause 
a public health emergency; or 
"(B) a priority to diagnose conditions that may result 
in adverse health consequences or death and may be caused 
by the administering of a drug, biological product, device, 
vaccine, vaccine adjuvant, antiviral, or diagnostic test that 
is a priority under subpsu-agraph (A).". 
SEC. 126. EVALUATION OF NEW AND EMERGING TECHNOLOGIES 42 USC 
REGARDING BIOTERRORIST ATTACK AND OTHER PUBLIC 300hh-13. 
HEALTH EMERGENCIES. 
(a) IN GENERAL.—The Secret2iry of Health and Human Services 
(referred to in this section as the "Secretary") shall promptly carry 
out a program to periodically evaluate new and emerging tech-
nologies that, in the determination of the Secretary, are designed 
to improve or enhance the ability of public health or safety officials 
to conduct public health surveillance activities relating to a bioter-
rorist attack or other public health emergency. 
(b) CERTAIN ACTIVITIES.—In carrying out this subsection, the 
Secretary shall, to the extent practicable— 
(1) survey existing technology programs funded by the Fed-
eral Government for potentially useful technologies; 
(2) promptly issue a request, as necessary, for information 
from non-Federal public and private entities for ongoing activi-
ties in this area; and 
(3) evaluate technologies identified under paragraphs (1) 
and (2) pursuant to subsection (c). 
(c) CONSULTATION AND EVALUATION.—In carrying out sub-
section (b)(3), the Secretary shall consult with the working group 
under section 319F(a) of the Public HesJth Service Act, as well 
as other appropriate public, nonprofit, and private entities, to 
develop criteria for the evaluation of such technologies and to con-
duct such evaluations. 
(d) REPORT.—Not later than 180 days after the date of the Deadline, 
enactment of this Act, and periodically thereafter, the Secretary 
shall submit to the Committee on Energy and Commerce of the 
House of Representatives, and the Committee on HegJth, Education, 
Labor, and Pensions of the Senate, a report on the activities under 
this section. 
SEC. 127. POTASSIUM IODIDE. 
(a) IN GENERAL.—Through the national stockpile under section 
121, the President, subject to subsections (b) and (c), shgdl make 
available to State and local governments potassium iodide tablets 
for stockpiling and for distribution as appropriate to public facilities, 
such as schools and hospitals, in quantities sufficient to provide 
adequate protection for the population within 20 miles of a nuclear 
power plant. 
(b) STATE AND LOCAL PLANS.— 
(1) IN GENERAL.—Subsection (a) applies with respect to 
a State or local government, subject to paragraph (2), if the 
government involved meets the following conditions: 
42 USC 
300hh-12 note. 
99-194 0-03-21 :QL3Partl 
116 STAT. 616 
PUBLIC LAW 107-188-^UNE 12, 2002 
Deadline. 
Deadline. 
Contracts. 
(A) Such government submits to the President a plan 
for the stockpiUng of potassium iodide tablets, and for 
the distribution and utilization of potassium iodide tablets 
in the event of a nuclear incident. 
(B) The plan is accompanied by certifications by such 
government that the government has not already received 
sufficient quantities of potassium iodide tablets from the 
Federal Government. 
(2) LOCAL GOVERNMENTS.—Subsection (a) applies with 
respect to a local government only if, in addition to the condi-
tions described in paragraph (1), the following conditions are 
met: 
(A) The State in which the locality involved is located— 
(i) does not have a plan described in paragraph 
(l)(A);or 
(ii) has a plan described in such paragraph, but 
the plan does not address populations at a distance 
greater than 10 miles from the nuclear power plant 
involved. 
(B) The local government has petitioned the State to 
modify the State plan to address such populations, not 
exceeding 20 miles from such plant, and 60 days have 
elapsed without the State modifying the State plan to 
address populations at the full distance sought by the 
local government through the petition. 
(C) The local government has submitted its local plan 
under paragraph (1)(A) to the State, and the State has 
approved the plan and certified that the plan is not incon-
sistent with the State emergency plan. 
(c) GUIDELINES.—Not later than one year after the date of 
the enactment of this Act, the President, in consultation with 
individuals representing appropriate Federal, State, and local agen-
cies, shall establish guidelines for the stockpiling of potassium 
iodide tablets, and for the distribution and utilization of potassium 
iodide tablets in the event of a nuclear incident. Such tablets 
may not be made available under subsection (a) until such guide-
lines have been established. 
(d) INFORMATION.—The President shall carry out activities to 
inform State and local governments of the program under this 
section. 
(e) REPORTS.— 
(1) PRESIDENT.—Not later than six months after the date 
on which the guidelines under subsection (c) are issued, the 
President shall submit to the Congress a report— 
(A) on whether potassium iodide tablets have been 
made available under subsection (a) or other Federal, State, 
or local programs, and the extent to which State and local 
governments have established stockpiles of such tablets; 
and 
(B) the measures taken by the President to implement 
this section. 
(2) NATIONAL ACADEMY OF SCIENCES.— 
(A) IN GENERAL.—^The President shall request the 
National Academy of Sciences to enter into an agreement 
with the President under which the Academy conducts 
a study to determine what is the most effective and safe 
way to distribute and administer potassium iodide tablets 
PUBLIC LAW 1 0 7 - 1 8 8 - J U N E 12, 2002 
116 STAT. 617 
on a mass scale. If the Academy declines to conduct the 
study, the President shall enter into an agreement with 
another appropriate public or nonprofit private entity to 
conduct the study. 
(B) REPORT.—The President shall ensure that, not later Deadline, 
than six months after the date of the enactment of this 
Act, the study required in subparagraph (A) is completed 
and a report describing the findings made in the study 
is submitted to the Congress, 
(f) APPLICABILITY.—Subsections (a) and (d) cease to apply as 
requirements if the President determines that there is an alter-
native and more effective prophylaxis or preventive measures for 
adverse thyroid conditions that may result from the release of 
radionuclides from nuclear power plants. 
Subtitle C—Improving State, Local, and 
Hospital Preparedness for and Response 
to Bioterrorism and Other Public Health 
Emergencies 
SEC. 131. GRANTS TO IMPROVE STATE, LOCAL, AND 
HOSPITAL 
PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM 
AND OTHER PUBLIC HEALTH EMERGENCIES. 
(a) IN GENERAL.—^Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.) is amended by inserting after section 
319C the following sections: 
"SEC. 319C-1. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL 
42 USC 247d-3a. 
PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM 
AND OTHER PUBLIC HEALTH EMERGENCIES. 
"(a) IN GENERAL.—To enhance the security of the United States 
with respect to bioterrorism and other public health emergencies, 
the Secretary shall make awards of grants or cooperative agree-
ments to eligible entities to enable such entities to conduct the 
activities described in subsection (d). 
"(b) ELIGIBLE ENTITIES.— 
"(1) IN GENERAL.—To be eligible to receive an award under 
subsection (a), an entity shall— 
"(A)(i) be a State; and 
"(ii) prepare and submit to the Secretary an application 
at such time, and in such manner, and containing such 
information as the Secretary may require, including an 
assurance that the State— 
"(I) has completed an evaluation under section 
319B(a), or an evaluation that is substantially equiva-
lent to an evaluation described in such section (as 
determined by the Secretary); 
"(II) has prepared, or will (within 60 days of 
receiving an award under this section) prepare, a Bio-
terrorism 
and 
Other 
Public 
Health 
Emergency 
Preparedness and Response Plan in accordance with 
subsection (c); 
"(III) has established a means by which to obtain 
public comment and input on the plan prepared under 
subclause (II), and on the implementation of such plan. 
116 STAT. 618 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
that shall include an advisory committee or other 
similar mechanism for obtaining comment from the 
public at large as well as from other State and local 
stakeholders; 
"(IV) will use amounts received under the award 
in accordance with the plan prepared under subclause 
(II), including making expenditures to carry out the 
strategy contained in the plan; and 
"(V) with respect to the plan prepared under sub-
clause (II), will establish reasonable criteria to evaluate 
the effective performance of entities that receive funds 
under the award and include relevant benchmarks in 
the plan; or 
"(B)(i) be a political subdivision of a State or a consor-
tium of 2 or more such subdivisions; and 
"(ii) prepare and submit to the Secretary an application 
at such time, and in such manner, and containing such 
information as the Secretary may require. 
"(2) COORDINATION WITH STATEWIDE PLANS.—^An award 
under subsection (a) to an eligible entity described in paragraph 
(1)(B) may not be made unless the application of such entity 
is in coordination with, and consistent with, applicable State-
wide plans described in subsection (d)(1). 
"(c) BlOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCY 
Deadline. 
PREPAREDNESS AND RESPONSE PLAN.—Not later than 60 days after 
receiving amoimts under an award under subsection (a), an eligible 
entity described in subsection (b)(1)(A) shall prepare and submit 
to the Secretary a Bioterrorism and Other Public Health Emergency 
Preparedness and Response Plan. Recognizing the assessment of 
public health needs conducted under section 319B, such plan shall 
include a description of activities to be carried out by the entity 
to address the needs identified in such assessment (or an equivalent 
assessment). 
"(d) USE OF FUNDS.—^An award under subsection (a) may be 
expended for activities that may include the following and similar 
activities: 
"(1) To develop Statewide plans (including the development 
of the Bioterrorism and Other Public Health Emergency 
Preparedness and Response Plan required under subsection 
(c)), and community-wide plans for responding to bioterrorism 
and other public health emergencies that are coordinated with 
the capacities of applicable national. State, and local health 
agencies and health care providers, including poison control 
centers. 
"(2) To address deficiencies identified in the assessment 
conducted under section 319B. 
"(3) To purchase or upgrade equipment (including sta-
tionary 
or mobile 
communications 
equipment), 
supplies, 
pharmaceuticals or other priority countermeasures to enhance 
preparedness for and response to bioterrorism or other public 
health emergencies, consistent with the plan described in sub-
section (c). 
"(4) To conduct exercises to test the capability and timeli-
ness of public health emergency response activities. 
"(5) To develop and implement the trauma care and bum 
center care components of the State plans for the provision 
of emergency medical services. 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 619 
"(6) To improve training or workforce development to 
enhance public health laboratories. 
"(7) To train public health and health care personnel to 
enhance the ability of such personnel— 
"(A) to detect, provide accurate identification of, and 
recognize the symptoms and epidemiological characteristics 
of exposure to a biological agent that may cause a public 
health emergency; and 
"(B) to provide treatment to individuals who are 
exposed to such an agent. 
"(8) To develop, enhance, coordinate, or improve participa-
tion in systems by which disease detection and information 
about biological attacks and other public health emergencies 
can be rapidly communicated among national. State, and local 
health agencies, emergency response personnel, and health care 
providers and facilities to detect and respond to a bioterrorist 
attack or other public health emergency, including activities 
to improve information technology and communications equip-
ment available to health care and public health officials for 
use in responding to a biological threat or attack or other 
public health emergency. 
"(9) To enhance communication to the public of information 
on bioterrorism and other public health emergencies, including 
through the use of 2-1-1 call centers. 
"(10) To address the health security needs of children and 
other vulnerable populations with respect to bioterrorism and 
other public health emergencies. 
"(11) To provide training and develop, enhance, coordinate, 
or improve methods to enhance the safety of workers and 
workplaces in the event of bioterrorism. 
"(12) To prepare and plan for contamination prevention 
efforts related to public health that may be implemented in 
the event of a bioterrorist attack, including training and plan-
ning to protect the health and safety of workers conducting 
the activities described in this paragraph. 
"(13) To prepare a plan for triage and transport manage-
ment in the event of bioterrorism or other public health emer-
gencies. 
"(14) To enhance the training of health care professionals 
to recognize and treat the mental health consequences of bioter-
rorism or other public health emergencies. 
"(15) To enhance the training of health care professionals 
to assist in providing appropriate health care for large numbers 
of individuals exposed to a bioweapon. 
"(16) To enhance training and planning to protect the 
health and safety of personnel, including health care profes-
sionals, involved in responding to a biological attack. 
"(17) To improve surveillance, detection, and response 
activities to prepare for emergency response activities including 
biological threats or attacks, including training personnel in 
these and other necessary functions and including early 
warning and surveillance networks that use advanced informa-
tion technology to provide early detection of biological threats 
or attacks. 
"(18) To develop, enhance, and coordinate or improve the 
ability of existing telemedicine programs to provide health care 
116 STAT. 620 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
information and advice as part of the emergency public health 
response to bioterrorism or other public health emergencies. 
Nothing in this subsection may be construed as establishing new 
regulatory authority or as modifying any existing regulatory 
authority. 
"(e) PRIORITIES IN USE OF GRANTS.— 
"(1) I N GENERAL.— 
"(A) PRIORITIES.—Except as provided in subparagraph 
(B), the Secretary shall, in carrying out the activities 
described in this section, address the following hazards 
in the following priority: 
"(i) Bioterrorism or acute outbreaks of infectious 
diseases. 
"(ii) Other public health threats and emergencies. 
"(B) DETERMINATION OF THE SECRETARY.—In the case 
of the hazard involved, the degree of priority that would 
apply to the hazard based on the categories specified in 
clauses (i) and (ii) of subparagraph (A) may be modified 
by the Secretary if the following conditions are met: 
"(i) The Secretary determines that the modification 
is appropriate on the basis of the following factors: 
"(I) The extent to which eligible entities are 
adequately prepared for responding to hazards 
within the category specified in clause (i) of 
subparagraph (A). 
"(II) There has been a significant change in 
the assessment of risks to the public health posed 
by hazards within the category specified in clause 
(ii) of such subparagraph. 
"(ii) Prior to modifying the priority, the Secretary 
notifies the appropriate committees of the Congress 
of the determination of the Secretary under clause 
(i) of this subparagraph. 
"(2) AREAS OF EMPHASIS WITHIN CATEGORIES.—The Sec-
retary shall determine areas of emphasis within the category 
of hazards specified in clause (i) of paragraph (1)(A), and shall 
determine areas of emphasis within the category of hazards 
specified in clause (ii) of such paragraph, based on an assess-
ment of the risk and likely consequences of such hazards and 
on an evaluation of Federal, State, and local needs, and may 
also take into account the extent to which receiving an award 
under subsection (a) will develop capacities that can be used 
for public health emergencies of varying types. 
"(f) CERTAIN ACTIVITIES.—In administering activities under sec-
tion 319C(c)(4) or similar activities, the Secretary shall, where 
appropriate, give priority to activities that include State or local 
government financial commitments, that seek to incorporate mul-
tiple public health and safety services or diagnostic databases into 
an integrated public health entity, and that cover geographic areas 
lacking advanced diagnostic and laboratory capabilities. 
"(g) COORDINATION WITH LOCAL MEDICAL RESPONSE SYSTEM.— 
An eligible entity and local Metropolitan Medical Response Systems 
shall, to the extent practicable, ensure that activities carried out 
under an award under subsection (a) are coordinated with activities 
that are carried out by local Metropolitan Medical Response Sys-
tems. 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 621 
"(h) COORDINATION OF FEDERAL ACTIVITIES.—In making awards 
under subsection (a), the Secretary shall— 
"(1) annually notify the Director of the Federal Emergency 
Management Agency, the Director of the Office of Justice Pro-
grams, and the Director of the National Domestic Preparedness 
Office, as to the amount, activities covered under, and status 
of such awards; and 
"(2) coordinate such awards with other activities conducted 
or supported by the Secretary to enhance preparedness for 
bioterrorism and other public health emergencies. 
"(i) DEFINITION.—For purposes of this section, the term 'eligible 
entity' means an entity that meets the conditions described in 
subparagraph (A) or (B) of subsection (b)(1). 
"(j) FUNDING.— 
"(1) AUTHORIZATIONS OF APPROPRIATIONS.— 
"(A) FISCAL YEAR 2003.— 
"(i) AUTHORIZATIONS.—For the purpose of carrying 
out this section, there is authorized to be appropriated 
$1,600,000,000 for fiscal year 2003, of which— 
"(I) $1,080,000,000 is authorized to be appro-
priated for awards pursuant to paragraph (3) (sub-
ject to the authority of the Secretary to make 
awards pursuant to paragraphs (4) and (5)); and 
"(II) 
$520,000,000 
is 
authorized 
to be 
appropriated— 
"(aa) for awards under subsection (a) to 
States, notwitstanding the eligibility condi-
tions under subsection (b), for the purpose of 
enhancing the preparedness of hospitals 
(including children's hospitals), clinics, health 
centers, and primary care facilities for bioter-
rorism and other public health emergencies; 
and 
"(bb) for Federal, State, and local planning 
and administrative activities related to such 
purpose. 
"(ii) CONTINGENT ADDITIONAL AUTHORIZATION.—If 
a significant change in circumstances warrants an 
increase in the amount authorized to be appropriated 
under clause (i) for fiscal year 2003, there are author-
ized to be appropriated such sums as may be necessary 
for such year for carrying out this section, in addition 
to the amount authorized in clause (i). 
"(B) OTHER FISCAL YEARS.—For the purpose of carrying 
out this section, there are authorized to be appropriated 
such sums as may be necessary for each of the fiscal 
years 2004 through 2006. 
"(2) SUPPLEMENT NOT SUPPLANT.—^Amounts appropriated 
under paragraph (1) shall be used to supplement and not sup-
plant other State and local public funds provided for activities 
under this section. 
"(3) STATE BIOTERRORISM AND OTHER PUBLIC HEALTH EMER-
GENCY PREPAREDNESS AND RESPONSE BLOCK GRANT FOR FISCAL 
YEAR 2003.— 
116 STAT. 622 
PUBLIC LAW 107-188-^lJNE 12, 2002 
"(A) IN GENERAL.—For fiscal year 2003, the Secretary 
shall, in an amount determined in accordance with sub-
paragraphs (B) through (D), make an award under sub-
section (a) to each State, notwithstanding the eligibility 
conditions described in subsection (b), that submits to the 
Secretary an application for the award that meets the 
criteria of the Secretary for the receipt of such an award 
and that meets other implementation conditions estab-
lished by the Secretary for such awards. No other awards 
may be made under subsection (a) for such fiscal year, 
except as provided in paragraph (l)(A)(i)(II) and paragraphs 
(4) and (5). 
"(B) BASE AMOUNT.—In determining the amount of an 
award pursuant to subparagraph (A) for a State, the Sec-
retary shall first determine an amount the Secretary con-
siders appropriate for the State (referred to in this para-
graph as the 'base amount'), except that such amount may 
not be greater than the minimum amount determined 
under subparagraph (D). 
"(C) INCREASE ON BASIS OF POPULATION.—After deter-
mining the base amount for a State under subparagraph 
(B), the Secretary shall increase the base amount by an 
amount equal to the product of— 
"(i) the amount appropriated under paragraph 
(l)(A)(i)(I) for the fiscal year, less an amount equal 
to the sum of all base amounts determined for the 
States under subparagraph (B), and less the amount, 
if any, reserved by the Secretary under paragraphs 
(4) and (5); and 
"(ii) subject to paragraph (4)(C), the percentage 
constituted by the ratio of an amount equal to the 
population of the State over an amount equal to the 
total population of the States (as indicated by the 
most recent data collected by the Bureau of the 
Census). 
"(D) MINIMUM AMOUNT.—Subject to the amount appro-
priated under paragraph (l)(A)(i)(I), an award pursuant 
to subparagraph (A) for a State shall be the greater of 
the base amount as increased under subparagraph (C), 
or the minimum amount under this subparagraph. The 
minimum amount under this subparagraph is— 
"(i) in the case of each of the several States, the 
District of Columbia, and the Commonwealth of Puerto 
Rico, an amount equal to the lesser o
f
— 
"(I) $5,000,000; or 
"(II) if the amount appropriated under para-
graph (l)(A)(i)(I) is less than $667,000,000, an 
amount equal to 0.75 percent of the amount appro-
priated under such paragraph, less the amount, 
if any, reserved by the Secretary under paragraphs 
(4) and (5); or 
"(ii) in the case of each of American Samoa, Guam, 
the Commonwealth of the Northern Mariana Islands, 
and the Virgin Islands, an amount determined by the 
Secretary to be appropriate, except that such amount 
may not exceed the amount determined under clause 
(i). 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
116 STAT. 623 
"(4) CERTAIN POLITICAL SUBDIVISIONS.— 
"(A) IN GENERAL.—For fiscal year 2003, the Secretary 
may, before making awards pursuant to paragraph (3) 
for such year, reserve from the amount appropriated under 
paragraph (l)(A)(i)(I) for the year an amount determined 
necessary by the Secretary to make awards under sub-
section (a) to poHtical subdivisions that have a substantial 
number of residents, have a substantial local infrastructure 
for responding to public health emergencies, and face a 
high degree of risk from bioterrorist attacks or other public 
health emergencies. Not more than three political subdivi-
sions may receive awards pursuant to this subparagraph. 
"(B) COORDINATION WITH STATEWIDE PLANS.—^An award 
pursuant to subparagraph (A) may not be made unless 
the application of the political subdivision involved is in 
coordination with, and consistent with, applicable State-
wide plans described in subsection (c). 
"(C) RELATIONSHIP TO FORMULA GRANTS.—In the case 
of a State that will receive an award pursuant to paragraph 
(3), and in which there is located a political subdivision 
that will receive an award pursuant to subparagraph (A), 
the Secretary shall, in determining the amount under para-
graph (3)(C) for the State, subtract from the population 
of the State an amount equal to the population of such 
political subdivision. 
"(D) 
CONTINUITY 
OF 
FUNDING.—In 
determining 
whether to make an award pursuant to subparagraph (A) 
to a political subdivision, the Secretary may consider, as 
a factor indicating that the award should be made, that 
the political subdivision received public health funding from 
the Secretary for fiscal year 2002. 
"(5) SIGNIFICANT UNMET NEEDS; DEGREE OF RISK.— 
"(A) IN GENERAL.—For fiscal year 2003, the Secretary 
may, before making awards pursuant to paragraph (3) 
for such year, reserve from the amount appropriated under 
paragraph (l)(A)(i)(I) for the year an amount determined 
necessary by the Secretary to make awards under sub-
section (a) to eligible entities that— 
"(i) have a significant need for funds to build 
capacity to identify, detect, monitor, and respond to 
a bioterrorist or other threat to the public health, 
which need will not be met by awards pursuant to 
paragraph (3); and 
"(ii) face a particularly high degree of risk of such 
a threat. 
"(B) RECIPIENTS OF GRANTS.—^Awards pursuant to 
subparagraph (A) may be supplemental awards to States 
that receive awards pursuant to paragraph (3), or may 
be awards to eligible entities described in subsection 
(b)(1)(B) within such States. 
"(C) 
FINDING 
WITH 
RESPECT 
TO 
DISTRICT OF 
COLUMBIA.—The Secretary shall consider the District of 
Columbia to have a significant unmet need for purposes 
of subparagraph (A), and to face a particularly high degree 
of risk for such purposes, on the basis of the concentration 
of entities of national significance located within the Dis-
trict. 
116 STAT. 624 
PUBLIC LAW 107-188-^UNE 12, 2002 
"(6) FUNDING OF LOCAL ENTITIES.—For fiscal year 2003, 
the Secretary shall in making awards under this section ensure 
that appropriate portions of such awards are made available 
to political subdivisions, local departments of public health, 
hospitals (including children's hospitals), clinics, health centers, 
or primary care facilities, or consortia of such entities. 
42 use 247d-3b. 
"SEC. 
319C-2. PARTNERSHIPS FOR 
COMMUNITY AND HOSPITAL 
PREPAREDNESS. 
"(a) GRANTS.—The Secretary shall make awards of grants or 
cooperative agreements to eligible entities to enable such entities 
to improve community and hospital preparedness for bioterrorism 
and other public health emergencies. 
"(b) ELIGIBILITY.—^To be eligible for an award under subsection 
(a), an entity shall— 
"(1) be a partnership consisting of— 
"(A) one or more hospitals (including children's hos-
pitals), clinics, health centers, or primary care facilities; 
and 
"(B)(i) one or more political subdivisions of States; 
"(ii) one or more States; or 
"(iii) one or more States and one or more political 
subdivisions of States; and 
"(2) prepare, in consultation with the Chief Executive 
Officer of the State, District, or territory in which the hospital, 
clinic, health center, or primary care facility described in para-
graph (1)(A) is located, and submit to the Secretary, an applica-
tion at such time, in such manner, and containing such informa-
tion as the Secretary may require. 
"(c) REGIONAL COORDINATION.—In making awards under sub-
section (a), the Secretary shall give preference to eligible entities 
that submit applications that, in the determination of the Secretary, 
will— 
"(1) enhance coordination— 
"(A) among the entities described in 
subsection 
(b)(1)(A); and 
"(B) between such entities and the entities described 
in subsection (b)(1)(B); and 
"(2) serve the needs of a defined geographic area. 
"(d) CONSISTENCY OF PLANNED ACTIVITIES.—An entity described 
in subsection (b)(1) shall utilize amounts received under an award 
under subsection (a) in a manner that is coordinated and consistent, 
as determined by the Secretary, with an applicable State Bioter-
rorism and Other Public Health Emergency Preparedness and 
Response Plan. 
"(e) USE OF FUNDS.—^An award under subsection (a) may be 
expended for activities that may include the following and similar 
activities— 
"(1) planning and administration for such award; 
"(2) preparing a plan for triage and transport management 
in the event of bioterrorism or other public health emergencies; 
"(3) enhancing the training of health care professionals 
to improve the ability of such professionals to recognize the 
symptoms of exposure to a potential bioweapon, to make appro-
priate diagnosis, and to provide treatment to those individuals 
so exposed; 
PUBLIC LAW 107-188-JUNE 12, 2002 
116 STAT. 625 
"(4) enhancing the training of health care professionals 
to recognize and treat the mental health consequences of bioter-
rorism or other public health emergencies; 
"(5) enhancing the training of health care professionals 
to assist in providing appropriate health care for large numbers 
of individuals exposed to a bioweapon; 
"(6) enhancing training and planning to protect the health 
and safety of personnel involved in responding to a biological 
attack; 
"(7) developing and implementing the trauma care and 
bum center care components of the State plans for the provision 
of emergency medical services; or 
"(8) conducting such activities as are described in section 
319C-l(d) that are appropriate for hospitals (including chil-
dren's hospitals), clinics, health centers, or primary care facili-
ties. 
"(f) LIMITATION ON AWARDS.^A political subdivision of a State 
shall not participate in more than one partnership described in 
subsection (b)(1). 
"(g) PRIORITIES IN USE OF GRANTS.— 
"(1) IN GENERAL.— 
"(A) PRIORITIES.—^Except as provided in subparagraph 
(B), the Secretary shall, in carrying out the activities 
described in this section, address the following hazards 
in the following priority: 
"(i) Bioterrorism or acute outbreaks of infectious 
diseases. 
"(ii) Other public health threats and emergencies. 
"(B) DETERMINATION OF THE SECRETARY.—In the case 
of the hazard involved, the degree of priority that would 
apply to the hazard based on the categories specified in 
clauses (i) £md (ii) of subparagraph (A) may be modified 
by the Secretary if the following conditions are met: 
"(i) The Secretary determines that the modification 
is appropriate on the basis of the following factors: 
"(I) The extent to which eligible entities are 
adequately prepared for responding to hazards 
within the category specified in clause (i) of 
subparagraph (A). 
"(II) There has been a significant change in 
the assessment of risks to the public health posed 
by hazards within the category specified in clause 
(ii) of such subparagraph. 
"(ii) Prior to modifying the priority, the Secretary 
notifies the appropriate committees of the Congress 
of the determination of the Secretary under clause 
(i) of this subparagraph. 
"(2) AREAS OF EMPHASIS WITHIN CATEGORIES.—The Sec-
retary shall determine areas of emphasis within the category 
of hazards specified in clause (i) of paragraph (1)(A), and shall 
determine areas of emphasis within the category of hazards 
specified in clause (ii) of such paragraph, based on an assess-
ment of the risk and likely consequences of such hazards and 
on an evaluation of Federal, State, and local needs, and may 
also take into account the extent to which receiving an award 
under subsection (a) will develop capacities that can be used 
for public health emergencies of varying types. 
116 STAT. 626 
PUBLIC LAW 107-188-^UNE 12, 2002 
"(h) COORDINATION WITH LOCAL MEDICAL RESPONSE SYSTEM.— 
An eligible entity and local Metropolitan Medical Response Systems 
shall, to the extent practicable, ensure that activities carried out 
under an award under subsection (a) are coordinated with activities 
that are carried out by local Metropolitan Medical Response Sys-
tems. 
"(i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
such sums as may be necessary for each of fiscal years 2004 through 
2006.". 
(b) CERTAIN GRANTS.—Section 319C of the Public Health 
Service Act (42 U.S.C. 247d-3) is amended by striking subsection 
(f). 
Subtitle D—Emergency Authorities; 
Additional Provisions 
SEC. 141. 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) DATA SUBMITTAL AND REPORTING DEADLINES.—In any case 
in which the Secretary determines that, wholly or partially as 
a result of a public health emergency that has been determined 
pursuant to subsection (a), individuals or public or private entities 
are unable to comply with deadlines for the submission to the 
Secretary of data or reports required under any law administered 
by the Secretary, the Secretary may, notwithstanding any other 
provision of law, grant such extensions of such deadlines as the 
circumstances reasonably require, and may waive, wholly or par-
tially, any sanctions otherwise applicable to such failure to comply. 
Federal Register, 
Before or promptly after granting such an extension or waiver, 
publication. 
the Secretary shall notify the Congress of such action and publish 
in the Federal Register a notice of the extension or waiver.". 
SEC. 142. STREAMLINING AND CLARIFYING COMMUNICABLE DISEASE 
QUARANTINE PROVISIONS. 
(a) ELIMINATION OF PREREQUISITE FOR NATIONAL ADVISORY 
HEALTH COUNCIL RECOMMENDATION BEFORE ISSUING QUARANTINE 
RULES.— 
(1) EXECUTIVE ORDERS SPECIFYING DISEASES SUBJECT TO 
INDIVIDUAL DETENTIONS.—Section 361(b) of the Public Health 
Act (42 U.S.C. 264(b)) is amended by striking "Executive orders 
of the President upon the recommendation of the National 
Advisory Health Council and the Surgeon General" and 
inserting "Executive orders of the President upon the rec-
ommendation of the Secretary, in consultation with the Surgeon 
General,". 
(2) REGULATIONS PROVIDING FOR APPREHENSION OF INDIVID-
UALS.—Section 361(d) of the Public Health Act (42 U.S.C. 
264(d)) is amended by striking "On recommendation of the 
National Advisory Health Council, regulations" and inserting 
"Regulations". 
(3) REGULATIONS PROVIDING FOR APPREHENSION OF INDIVID-
UALS IN WARTIME.—Section 363 of the Public Health Act (42 
U.S.C. 266) is amended by striking "the Surgeon General, on 
recommendation of the National Advisory Health Council," and 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 627 
inserting "the Secretary, in consultation with the Surgeon Gen-
eral,". 
(b) APPREHENSION AUTHORITY TO APPLY IN CASES OF EXPOSURE 
TO DISEASE.— 
(1) REGULATIONS PROVIDING FOR APPREHENSION OF INDIVID-
UALS.—Section 361(d) of the Public Health Act (42 U.S.C. 
264(d)), as amended by subsection (a)(2), is further amended— 
(A) by striking "(1)" and "(2)" and inserting "(A)" and 
"(B)", respectively; 
(B) by striking "(d)" and inserting "(d)(1)"; 
(C) in paragraph (1) (as designated by subparagraph 
(B) of this paragraph), in the first sentence, by striking 
"in a communicable stage" each place such term appears 
and inserting "in a qualifying stage"; and 
(D) by adding at the end the following paragraph: 
"(2) For purposes of this subsection, the term 'qualifying stage', 
with respect to a communicable disease, means that such disease— 
"(A) is in a communicable stage; or 
"(B) is in a precommunicable stage, if the disease would 
be likely to cause a public health emergency if transmitted 
to other individuals.". 
(2) REGULATIONS PROVIDING FOR APPREHENSION OF INDIVID-
UALS IN WARTIME.—Section 363 of the Pubhc Health Act (42 
U.S.C. 266), as amended by subsection (a)(3), is further 
amended by striking "in a communicable stage". 
(c) STATE AUTHORITY.—Section 361 of the Public Health Act 
(42 U.S.C. 264) is amended by adding at the end the following: 
"(e) Nothing in this section or section 363, or the regulations 
promulgated under such sections, may be construed as superseding 
any provision under State law (including regulations and including 
provisions established by political subdivisions of States), except 
to the extent that such a provision conflicts with an exercise of 
Federal authority under this section or section 363.". 
SEC. 143. EMERGENCY WAIVER OF MEDICARE, MEDICAID, AND SCHIP 
REQUIREMENTS. 
(a) WAIVER AUTHORITY.—Title XI of the Social Security Act 
(42 U.S.C. 1301 et seq.) is amended by inserting after section 
1134 the following new section: 
"AUTHORITY TO WAIVE REQUIREMENTS DURING NATIONAL 
EMERGENCIES 
"SEC. 1135. (a) PURPOSE.—The purpose of this section is to 42USCi320b-5. 
enable the Secretary to ensure to the maximum extent feasible, 
in any emergency area and during an emergency period (as defined 
in subsection (g)( 1))— 
"(1) that sufficient health care items and services are avail-
able to meet the needs of individuals in such area enrolled 
in the programs under titles XVTII, XIX, and XXI; and 
"(2) that health care providers (as defined in subsection 
(g)(2)) that furnish such items and services in good faith, but 
that are unable to comply with one or more requirements 
described in subsection (b), may be reimbursed for such items 
and services and exempted from sanctions for such noncompli-
ance, absent any determination of fraud or abuse. 
"(b) SECRETARIAL AUTHORITY.—^To the extent necessary to 
accomplish the purpose specified in subsection (a), the Secretary 
/ 
116 STAT. 628 
PUBLIC LAW 107-188—JUNE 12, 2002 
is authorized, subject to the provisions of this section, to temporarily 
waive or modify the appHcation of, with respect to health care 
items and services furnished by a health care provider (or classes 
of health care providers) in any emergency area (or portion of 
such an area) during any portion of an emergency period, the 
requirements of titles XVIII, XIX, or XXI, or any regulation there-
under (and the requirements of this title other than this section, 
and regulations thereunder, insofar as they relate to such titles), 
pertaining to— 
"(1)(A) conditions of participation or other certification 
requirements for an individual health care provider or types 
of providers, 
"(B) program participation and similar requirements for 
an individual health care provider or types of providers, and 
"(C) pre-approval requirements; 
"(2) requirements that physicians and other health care 
professionals be licensed in the State in which they provide 
such services, if they have equivalent licensing in another State 
and are not affirmatively excluded from practice in that State 
or in any State a part of which is included in the emergency 
area; 
"(3) sanctions under section 1867 (relating to examination 
and treatment for emergency medical conditions and women 
in labor) for a transfer of an individual who has not been 
stabilized in violation of subsection (c) of such section if the 
transfer arises out of the circumstances of the emergency; 
"(4) sanctions under section 1877(g) (relating to limitations 
on physician referral); 
"(5) deadlines and timetables for performance of required 
activities, except that such deadlines and timetables may only 
be modified, not waived; and 
"(6) limitations" on payments under section 185l(i) for 
health care items and services furnished to individuals enrolled 
in a Medicare+Choice plan by health care professionals or facili-
ties not included under such plan. 
Insofar as the Secretary exercises authority under paragraph (6) 
with respect to individuals enrolled in a Medicare+Choice plan, 
to the extent possible given the circumstances, the Secretary shall 
reconcile payments made on behalf of such enrollees to ensure 
that the enrollees do not pay more than would be required had 
they received services from providers within the network of the 
plan and may reconcile payments to the organization offering the 
plan to ensure that such organization pays for services for which 
payment is included in the capitation payment it receives under 
p a r t e of title XVIII. 
"(c) AUTHORITY FOR RETROACTIVE WAIVER.—^A waiver or modi-
fication of requirements pursuant to this section may, at the Sec-
retary's discretion, be made retroactive to the beginning of the 
emergency period or any subsequent date in such period specified 
by the Secretary. 
"(d) CERTIFICATION TO CONGRESS.—The Secretary shall provide 
a certification and advance written notice to the Congress at least 
two days before exercising the authority under this section with 
respect to an emergency area. Such a certification and notice shall 
include— 
"(1) a description of— 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 629 
"(A) the specific provisions that will be waived or modi-
fied; 
"(B) the health care providers to whom the waiver 
or modification will apply; 
"(C) the geographic area in which the waiver or modi-
fication will apply; and 
"(D) the period of time for which the waiver or modifica-
tion will be in effect; and 
"(2) a certification that the waiver or modification is nec-
essary to carry out the purpose specified in subsection (a). 
"(e) DURATION OF WAIVER.— 
"(1) IN GENERAL.—^A waiver or modification of requirements 
pursuant to this section terminates upon— 
"(A) the termination of the applicable declaration of 
emergency or disaster described in subsection (g)(1)(A); 
"(B) the termination of the applicable declaration of 
public health emergency described in subsection (g)(1)(B); 
or 
"(C) subject to paragraph (2), the termination of a 
period of 60 days from the date the waiver or modification 
is first published (or, if applicable, the date of extension 
of the waiver or modification under paragraph (2)). 
"(2) EXTENSION OF 60-DAY PERIODS.—The Secretary 
may, 
by notice, provide for an extension of a 60-day period described 
in paragraph (1)(C) (or an additional period provided under 
this paragraph) for additional period or periods (not to exceed, 
except as subsequently provided under this paragraph, 60 days 
each), but any such extension shall not affect or prevent the 
termination of a waiver or modification under subparagraph 
(A) or (B) of paragraph (1). 
"(f) REPORT TO CONGRESS.—^Within one year after the end of 
the emergency period in an emergency area in which the Secretary 
exercised the authority provided under this section, the Secretary 
shall report to the Congress regarding the approaches used to 
accomplish the purposes described in subsection (a), including an 
evaluation of such approaches and recommendations for improved 
approaches should the need for such emergency authority arise 
in the future. 
"(g) DEFINITIONS.—For purposes of this section: 
"(1) EMERGENCY AREA; EMERGENCY PERIOD.—^An 'emergency 
area' is a geographical area in which, and an 'emergency period' 
is the period during which, there exists— 
"(A) an emergency or disaster declared by the President 
pursuant to the National Emergencies Act or the Robert 
T. Stafford Disaster Relief and Emergency Assistance Act; 
and 
"(B) a public health emergency declared by the Sec-
retary pursuant to section 319 of the Public Health Service 
Act. 
"(2) HEALTH CARE PROVIDER.—The term 'health care pro-
vider' means any entity that furnishes health care items or 
services, and includes a hospital or other provider of services, 
a physician or other health care practitioner or professional, 
a health care facility, or a supplier of health care items or 
services.". 
(b) EFFECTIVE DATE.—The amendment made by subsection (a) 
42 use i320b-5 
shall be effective on and after September 11, 2001. 
note. 
116 STAT. 630 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
42 u s e 247d 
note. 
SEC. 144. PROVISION FOR EXPIRATION OF PUBLIC HEALTH EMER-
GENCIES. 
(a) IN GENERAL.—Section 319(a) of the Public Health Service 
Act (42 U.S.C. 247d(a)), is amended by adding at the end the 
following new sentence: "Any such determination of a public health 
emergency terminates upon the Secretary declaring that the emer-
gency no longer exists, or upon the expiration of the 90-day period 
beginning on the date on which the determination is made by 
the Secretary, whichever occurs first. Determinations that termi-
nate under the preceding sentence may be renewed by the Secretary 
(on the basis of the same or additional facts), and the preceding 
sentence applies to each such renewal. Not later than 48 hours 
after making a determination under this subsection of a public 
health emergency (including a renewal), the Secretary shall submit 
to the Congress written notification of the determination.". 
(b) APPLICABILITY.—^The amendment made by subsection (a) 
applies to any public health emergency under section 319(a) of 
the Public Health Service Act, including any such emergency that 
was in effect as of the day before the date of the enactment of 
this Act. In the case of such an emergency that was in effect 
as of such day, the 90-day period described in such section with 
respect to the termination of the emergency is deemed to begin 
on such date of enactment. 
Subtitle E—^Additional Provisions 
SEC. 151. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT 
PLAN. 
Section 613(b) of the Robert T. Stafford Disaster Relief and 
Emergency Assistance Act (42 U.S.C. 5196b(b)) is amended— 
(1) in paragraph (5), by striking "and" at the end; 
(2) in paragraph (6), by striking the period and inserting 
"; and"; and 
(3) by adding at the end the following: 
"(7) include a plan for providing information to the public 
in a coordinated manner.". 
42 u s e 7257d. 
SEC. 152. EXPANDED RESEARCH BY SECRETARY OF ENERGY. 
(a) DETECTION AND IDENTIFICATION RESEARCH.— 
(1) IN GENERAL.—In conjunction with the working group 
under section 319F(a) of the Public Health Service Act, the 
Secretary of Energy and the Administrator of the National 
Nuclear Security Administration shall expand, enhance, and 
intensify research relevant to the rapid detection and identifica-
tion of pathogens likely to be used in a bioterrorism attack 
or other agents that may cause a public health emergency. 
(2) AUTHORIZED ACTIVITIES.—^Activities carried out under 
paragraph (1) may include— 
(A) the improvement of methods for detecting biological 
agents or toxins of potential use in a biological attack 
and the testing of such methods under variable conditions; 
(B) the improvement or pursuit of methods for testing, 
verifying, and calibrating new detection and surveillance 
tools and techniques; and 
(C) carrying out other research activities in relevant 
areas. 
PUBLIC LAW 107-188^JUNE 12, 2002 
116 STAT. 631 
(3) REPORT.—Not later than 180 days after the date of Deadline. 
the enactment of this Act, the Administrator of the National 
Nuclear Security Administration shall submit to the Committee 
on Energy and Natural Resources and the Committee on Armed 
Services of the Senate, and the Committee on Energy and 
Commerce and the Committee on Armed Services of the House 
of Representatives, a report setting forth the programs and 
projects that will be funded prior to the obligation of funds 
appropriated under subsection (b). 
(b) AUTHORIZATION.—For the purpose of carrying out this sec-
tion, there are authorized to be appropriated such sums as may 
be necessary in each of fiscal years 2002 through 2006. 
SEC. 153. EXPANDED RESEARCH ON WORKER HEALTH AND SAFETY. 
29 USC 669a. 
The Secretary of Health and Human Services (referred to in 
this section as the "Secretary"), acting through the Director of 
the National Institute of Occupational Safety and Health, shall 
enhance and expand research as deemed appropriate on the health 
and safety of workers who are at risk for bioterrorist threats or 
attacks in the workplace, including research on the health effects 
of measures taken to treat or protect such workers for diseases 
or disorders resulting from a bioterrorist threat or attack. Nothing 
in this section may be construed as establishing new regulatory 
authority for the Secretary or the Director to issue or modify any 
occupational safety and health rule or regulation. 
SEC. 
154. ENHANCEMENT 
OF 
EMERGENCY 
PREPAREDNESS 
OF 
38 USC note 
DEPARTMENT OF VETERANS AFFAHIS. 
prec. 8101. 
(a) READINESS OF DEPARTMENT MEDICAL CENTER.—(1) The Sec-
retary of Veterans Affairs shall take appropriate actions to enhance 
the readiness of Department of Veterans Affairs medical centers 
to protect the patients and staff of such centers from chemical 
or biological attack or otherwise to respond to such an attack 
and so as to enable such centers to fulfil their obligations as 
part of the Federal response to public health emegencies. 
(2) Actions under paragraph (1) shall include— 
(A) the provision of decontamination equipment and per-
sonal protection equipment at Department medical centers; 
and 
(B) the provision of training in the use of such equipment 
to staff of such centers. 
(b) SECURITY AT DEPARTMENT MEDICAL AND RESEARCH FACILI-
T I E S . ^ ! ) Not later than 180 days after the date of the enactment Deadline, 
of this Act, the Secretary shall carry out an evaluation of the 
security needs at Department medical centers and research facili-
ties. The evaluation shall address the following needs: 
(A) Needs for the protection of patients and medical staff 
during emergencies, including a chemical or biological attack 
or other terrorist attack. 
(B) Needs, if any, for screening personnel engaged in 
research relating to biological pathogens or agents, including 
work associated with such research. 
(C) Needs for securing laboratories or other facilities 
engaged in research relating to biological pathogens or agents. 
(D) Any other needs the Secretary considers appropriate. 
(2) The Secretary shall take appropriate actions to enhance 
the security of Department medical centers and research facilities, 
including staff and patients at such centers and facilities. In taking 
116 STAT. 632 
PUBLIC LAW 107-188-^UNE 12, 2002 
such actions, the Secretary shall take into account the results 
of the evaluation required by paragraph (1). 
(c) TRACKING OF PHARMACEUTICALS AND MEDICAL SUPPLIES 
AND EQUIPMENT.—The Secretary shall develop and maintain a cen-
tralized system for tracking the current location and availability 
of pharmaceuticals, medical supplies, and medical equipment 
throughout the Department health care system in order to permit 
the ready identification and utilization of such pharmaceuticals, 
supplies, and equipment for a variety of purposes, including 
response to a chemical or biological attack or other terrorist attack. 
(d) TRAINING.—The Secretary shall ensure that the Department 
medical centers, in consultation with the accredited medical school 
affiliates of such medical centers, develop and implement curricula 
to train resident physicians and health care personnel in medical 
matters relating to biological, chemical, or radiological attacks. 
(e) PARTICIPATION IN NATIONAL DISASTER MEDICAL SYSTEM.— 
(1) The Secretary shall, in consultation with the Secretary of 
Defense, the Secretary of Health and Human Services, and the 
Director of the Federal Emergency Management Agency, establish 
and maintain a training program to facilitate the participation 
of the staff of Department medical centers, and of the community 
partners of such centers, in the National Disaster Medical System. 
(2) The Secretary shall establish and maintain the training 
program under paragraph (1) in accordance with the recommenda-
tions of the working group under section 319F(a) of the Public 
Health Service Act. 
(f) MENTAL HEALTH COUNSELING.—(1) With respect to activities 
conducted by personnel serving at Department medical centers, 
the Secretary shall, in consultation with the Secretary of Health 
and Human Services, the American Red Cross, and the working 
group under section 319F(a) of the Public Health Service Act, 
develop and maintain various strategies for providing mental health 
counseling and assistance, including counseling and assistance for 
post-traumatic stress disorder, to local and community emergency 
response providers, veterans, active duty military personnel, and 
individuals seeking care at Department medical centers following 
a bioterrorist attack or other public health emergency. 
(2) The strategies under paragraph (1) shall include the fol-
lowing: 
(A) Training and certification of providers of mental health 
counseling and assistance. 
(B) Mechanisms for coordinating the provision of mental 
health counseling and assistance to emergency response pro-
viders referred to in that paragraph. 
(g) AUTHORIZATION OF APPROPRIATIONS.—^There is hereby 
authorized to be appropriated for the Department of Veterans 
Affairs amounts as follows: 
(1) To carry out activities required by subsection (a)— 
(A) $100,000,000 for fiscal year 2002; and 
(B) such sums as may be necessary for each of fiscal 
years 2003 through 2006. 
(2) To carry out activities required by subsections (b) 
through (f)— 
(A) $33,000,000 for fiscal year 2002; and 
(B) such sums as may be necessary for each of fiscal 
years 2003 through 2006. 
PUBLIC LAW 107-188^JUNE 12, 2002 
116 STAT. 633 
SEC. 155. REAUTHORIZATION OF EXISTING PROGRAM. 
Section 582(f) of the Public Health Service Act (42 U.S.C. 
290hh-l(f)) is amended by striking "2002 and 2003" and inserting 
"2003 through 2006". 
SEC. 156. SENSE OF CONGRESS. 
It is the sense of the Congress 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 university centers 
and laboratories will contribute significantly to the United 
States capacity to defend against any biological threat or attack; 
(3) maximizing the effectiveness of, and extending the mis-
sion of, established university programs would be one appro-
priate use of the additional resources provided for in this Act 
and the amendments made by this Act; and 
(4) the Secretary of Health and Human Services should, 
as appropriate, recognize the importance of existing public and 
private university-based research, training, public awareness, 
and safety related biological defense programs when the Sec-
retary makes awards of grants and contracts in accordance 
with this Act and the amendments made by this Act. 
SEC. 157. GENERAL ACCOUNTING OFFICE REPORT. 
42 USC 300hh 
(a) IN GENERAL.—^The Comptroller General shall submit to 
the Committee on Health, Education, Labor, and Pensions and 
the Committee on Appropriations of the Senate, and to the Com-
mittee on Energy and Commerce and the Committee on Appropria-
tions of the House of Representatives, a report that describes— 
(1) Federal activities primarily related to research on, 
preparedness for, and the management of the public health 
and medical consequences of a bioterrorist attack against the 
civilian population; 
(2) the coordination of the activities described in paragraph 
(1); 
(3) the effectiveness of such efforts in preparing national, 
State, and local authorities to address the public health and 
medical consequences of a potential bioterrorist attack against 
the civilian population; 
(4) the activities and costs of the Civil Support Teams 
of the National Guard in responding to biological threats or 
attacks against the civilian population; 
(5) the activities of the working group under subsection 
(a) and the efforts made by such group to carry out the activities 
described in such subsection; and 
(6) the ability of private sector contractors to enhance 
governmental responses to biological threats or attacks. 
SEC. 158. CERTAIN AWARDS. 
Section 319(a) of the Public Health Service Act (42 U.S.C. 
247d(a)) is amended in the matter after and below paragraph (2) 
by striking "grants and" and inserting "grants, providing awards 
for expenses, and". 
116 STAT. 634 
PUBLIC LAW 107-188-^UNE 12, 2002 
Community 
SEC. 159. PUBLIC ACCESS DEFIBRILLATION PROGRAMS AND PUBLIC 
Access to 
ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS. 
Emergency 
, 
, 
../-, 
Defibrillation Act 
(a) SHORT TiTLE.—^This section may be cited as the Community 
of 2002. 
Access to Emergency Defibrillation Act of 2002". t 
42 use 244 note 
^
^
-
^ FINDINGS.—Congress makes the following findings: 
(1) Over 220,000 Americans die each year from cardiac 
arrest. Every 2 minutes, an individual goes into cardiac arrest 
in the United States. 
(2) The chance of successfully returning to a normal heart 
rhythm diminishes by 10 percent each minute following sudden 
cardiac arrest. 
(3) Eighty percent of cardiac arrests are caused by ventric-
ular fibrillation, for which defibrillation is the only effective 
treatment. 
(4) Sixty percent of all cardiac arrests occur outside the 
hospital. The average national survival rate for out-of-hospital 
cardiac arrest is only 5 percent. 
(5) Communities that have established and implemented 
public access defibrillation programs have achieved average 
survival rates for out-of-hospital cardiac arrest as high as 50 
percent. 
(6) According to the American Heart Association, wide use 
of defibrillators could save as many as 50,000 lives nationally 
each year. 
(7) Successful public access defibrillation programs ensure 
that cardiac arrest victims have access to early 911 notification, 
early cardiopulmonary resuscitation, early defibrillation, and 
early advanced care. 
(c) PUBLIC ACCESS DEFIBRILLATION PROGRAMS AND PROJECTS.— 
Part B of title III of the Public Health Service Act (42 U.S.C. 
243 et seq.), as amended by Public Law 106-310, is amended 
by adding after section 311 the following: 
42 use 244. 
«SEC. 312. PUBLIC ACCESS DEFIBRILLATION PROGRAMS. 
Grants. 
"(a) IN GENERAL.—^The Secretary shall award grants to States, 
political subdivisions of States, Indian tribes, and tribal organiza-
tions to develop and implement public access 
defibrillation 
programs— 
"(1) by training and equipping local emergency medical 
services personnel, including firefighters, police officers, para-
medics, emergency 
medical technicians, 
and 
other 
first 
responders, 
to 
administer 
immediate 
care, 
including 
cardiopulmonary 
resuscitation 
and 
automated 
external 
defibrillation, to cardiac arrest victims; 
"(2) by purchasing automated external 
defibrillators, 
placing the defibrillators in public places where cardiac arrests 
are likely to occur, and training personnel in such places to 
administer 
cardiopulmonary 
resuscitation 
and 
automated 
external defibrillation to cardiac arrest victims; 
"(3) by setting procedures for proper maintenance and 
testing of such devices, according to the guidelines of the manu-
facturers of the devices; 
"(4) by providing training to members of the public in 
cardiopulmonary 
resuscitation 
and 
automated 
external 
defibrillation; 
"(5) by integrating the emergency medical services system 
with the public access defibrillation programs so that emergency 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
116 STAT. 635 
medical services personnel, including dispatchers, are informed 
about the location of automated external defibrillators in their 
community; and 
"(6) by encouraging private companies, including small 
businesses, to purchase automated external defibrillators and 
provide 
training 
for 
their 
employees 
to 
administer 
cardiopulmonary 
resuscitation 
and 
external 
automated 
defibrillation to cardiac arrest victims in their community. 
"(b) PREFERENCE.—In awarding grants under subsection (a), 
the Secretary shall give a preference to a State, political subdivision 
of a State, Indian tribe, or tribal organization that— 
"(1) has a particularly low local survival rate for cardiac 
arrests, or a particularly low local response rate for cardiac 
arrest victims; or 
"(2) demonstrates in its application the greatest commit-
ment 
to establishing 
and 
maintaining 
a public 
access 
defibrillation program. 
"(c) USE OF FUNDS.—^A State, political subdivision of a State, 
Indian tribe, or tribal organization that receives a grant under 
subsection (a) may use funds received through such grant to— 
"(1) purchase automated external defibrillators that have 
been approved, or cleared for marketing, by the Food and 
Drug Administration; 
"(2) provide automated external defibrillation and basic 
life support training in automated external defibrillator usage 
through nationally recognized courses; 
"(3) provide information to community members about the 
public access defibrillation program to be funded with the grant; 
"(4) provide information to the local emergency medical 
services system regarding the placement of automated external 
defibrillators in public places; 
"(5) produce materials to encourage private companies, 
including small businesses, to purchase automated external 
defibrillators; and 
"(6) further develop strategies to improve access to auto-
mated external defibrillators in public places. 
"(d) APPLICATION.— 
"(1) IN GENERAL.—To be eligible to receive a grant under 
subsection (a), a State, political subdivision of a State, Indian 
tribe, or tribal organization shall prepare and submit an 
application to the Secretary at such time, in such manner, 
and containing such information as the Secretary may reason-
ably require. 
"(2) CONTENTS.—^An application submitted under para-
graph (1) shall— 
"(A) 
describe 
the 
comprehensive 
public 
access 
defibrillation program to be funded with the grant and 
demonstrate how such program would make automated 
external defibrillation accessible and available to cardiac 
arrest victims in the community; 
"(B) contain procedures for implementing appropriate 
nationally recognized training courses in 
performing 
cardiopulmonary resuscitation and the use of automated 
external defibrillators; 
"(C) contain procedures for ensuring direct involvement 
of a licensed medical professional and coordination with 
116 STAT. 636 
PUBLIC LAW 107-188—JUNE 12, 2002 
the local emergency medical services system in the over-
sight of training and notification of incidents of the use 
of the automated external defibrillators; 
"(D) contain procedures for proper maintenance and 
testing of the automated external defibrillators, according 
to the labeling of the manufacturer; 
"(E) contain procedures for ensuring notification of 
local 
emergency 
medical 
services 
system 
personnel, 
including dispatchers, of the location £ind type of devices 
used in the public access defibrillation program; and 
"(F) provide for the collection of data regarding the 
effectiveness of the public access defibrillation program 
to be funded with the grant in affecting the out-of-hospital 
cardiac arrest survival rate. 
"(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
$25,000,000 for fiscal year 2003, and such sums as may be necessary 
for each of the fiscal years 2004 through 2006. Not more than 
10 percent of amounts received under a grant awarded under this 
section may be used for administrative expenses. 
42 use 245. 
"SEC. 
313. 
PUBLIC ACCESS 
DEFIBRILLATION 
DEMONSTRATION 
PROJECTS. 
"(a) IN GENERAL.—The Secretary shall award grants to political 
subdivisions of States, Indian tribes, and tribal organizations to 
develop and implement innovative, comprehensive, community-
based public access defibrillation demonstration projects that— 
"(1) provide cardiopulmonary resuscitation and automated 
external defibrillation to cardiac arrest victims in unique set-
tings; 
"(2) 
provide 
training 
to 
community 
members 
in 
cardiopulmonary 
resuscitation 
and 
automated 
external 
defibrillation; and 
"(3) maximize community access to automated external 
defibrillators. 
"(b) USE OF FUNDS.—^A recipient of a grant under subsection 
(a) shall use the funds provided through the grant to— 
"(1) purchase automated external defibrillators that have 
been approved, or cleared for marketing, by the Food and 
Drug Administration; 
"(2) provide basic life training in automated external 
defibrillator usage through nationally recognized courses; 
"(3) provide information to community members about the 
public access defibrillation demonstration project to be funded 
with the grant; 
"(4) provide information to the local emergency medical 
services system regarding the placement of automated external 
defibrillators in the unique settings; and 
"(5) further develop strategies to improve access to auto-
mated external defibrillators in public places. 
"(c) APPLICATION.— 
"(1) IN GENERAL.—To be eligible to receive a grant under 
subsection (a), a political subdivision of a State, Indian tribe, 
or tribal organization shall prepare and submit an application 
to the Secretary at such time, in such manner, and containing 
such information as the Secretary may reasonably require. 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 637 
"(2) CONTENTS.—^An application submitted under para-
graph (1) may— 
"(A) describe the innovative, comprehensive, commu-
nity-based 
pubHc 
access 
defibrillation 
demonstration 
project to be funded with the grant; 
"(B) explain how such public access defibrillation dem-
onstration project represents innovation in providing public 
access to automated external defibrillation; and 
"(C) provide for the collection of data regarding the 
effectiveness of the demonstration project to be funded 
with the grant in— 
"(i) providing emergency cardiopulmonary resus-
citation and automated external defibrillation to car-
diac arrest victims in the setting served by the dem-
onstration project; and 
"(ii) affecting the cardiac arrest survival rate in 
the setting served by the demonstration project. 
"(d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized 
to be appropriated to carry out this section $5,000,000 for each 
of fiscal years 2002 through 2006. Not more than 10 percent of 
amounts received under a grant awarded under this section may 
be used for administrative expenses.". 
TITLE II—ENHANCING CONTROLS ON 
DANGEROUS 
BIOLOGICAL 
AGENTS 
AND TOXINS 
Subtitle A—Department of Health and 
Human Services 
SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS. 
(a) BIOLOGICAL AGENTS PROVISIONS OF THE ANTITERRORISM 
AND EFFECTIVE DEATH PENALTY ACT OF 1996; CODIFICATION IN 
THE PUBLIC HEALTH SERVICE ACT, WITH AMENDMENTS.—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 35LA. E N H A N C E D 
CONTROL OF DANGEROUS BIOLOGICAL 
42 USC 262a. 
AGENTS AND TOXINS. 
"(a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS 
AND TOXINS.— 
"(1) LIST OF BIOLOGICAL AGENTS AND TOXINS.— 
"(A) IN GENERAL.—The Secretary shall by regulation 
establish and maintain a list of each biological agent and 
each toxin that has the potential to pose a severe threat 
to public health and safety. 
"(B) CRITERIA.—In determining whether to include £in 
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; 
116 STAT. 638 
PUBLIC LAW 107-18a-JUNE 12, 2002 
"(11) the degree of contagiousness of the agent 
or toxin and the methods by which the agent or 
toxin is transferred to humans; 
"(III) the availabiUty and effectiveness of 
pharmacotherapies and immunizations to treat 
and prevent any illness resulting from infection 
by the agent or toxin; and 
"(IV) any other criteria, including the needs 
of children and other vulnerable populations, that 
the Secretary considers appropriate; and 
"(ii) consult with appropriate Federal departments 
and agencies and with scientific experts representing 
appropriate professional groups, including groups with 
pediatric expertise. 
"(2) BIENNIAL REVIEW.—^The Secretary shall review and 
republish the list under paragraph (1) biennially, or more often 
as needed, and shall by regulation revise the list as necessary 
in accordance with such paragraph. 
"(b) 
REGULATION OF TRANSFERS OF LISTED AGENTS AND 
TOXINS.—^The Secretary shall by regulation provide for— 
"(1) the establishment and enforcement of safety procedures 
for the transfer of listed agents and toxins, including measures 
to ensure— 
"(A) proper training and appropriate skills to handle 
such agents and toxins; and 
"(B) proper laboratory facilities to contain and dispose 
of such agents and toxins; 
"(2) the establishment and enforcement of safeguard and 
security measures to prevent access to such agents and toxins 
for use in domestic or international terrorism or for any other 
criminal purpose; 
"(3) the establishment of procedures to protect the public 
safety in the event of a transfer or potential transfer of such 
an agent or toxin in violation of the safety procedures estab-
lished under paragraph (1) or the safeguard and security meas-
ures established under paragraph (2); and 
"(4) appropriate availability of biological agents and toxins 
for research, education, and other legitimate purposes. 
"(c) POSSESSION AND USE OF LISTED AGENTS AND TOXINS.— 
The Secretary shall by regulation provide for the establishment 
and enforcement of standards and procedures governing the posses-
sion and use of listed agents and toxins, including the provisions 
described in paragraphs (1) through (4) of subsection (b), in order 
to protect the public health and safety. 
"(d) REGISTRATION; IDENTIFICATION; DATABASE.— 
"(1) REGISTRATION.—^Regulations under subsections (b) and 
(c) shall require registration with the Secretary of the posses-
sion, use, and transfer of listed agents and toxins, and shall 
include provisions to ensure that persons seeking to register 
under such regulations have a lawful purpose to possess, use, 
or transfer such agents and toxins, including provisions in 
accordance with subsection (e)(6). 
"(2) IDENTIFICATION; DATABASE.—Regulations under sub-
sections (b) and (c) shall require that registration include (if 
available to the person registering) information regarding the 
characterization of listed agents and toxins to facilitate their 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
116 STAT. 639 
identification, including their source. The Secretary shall main-
tain a national database that includes the names and locations 
of registered persons, the listed agents and toxins such persons 
are 
possessing, 
using, or trsinsferring, 
and 
information 
regarding the characterization of such agents and toxins. 
"(e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REGISTERED 
PERSONS.— 
"(1) IN GENERAL.—Regulations under subsections (b) and 
(c) shall include appropriate safeguard and security require-
ments for persons possessing, using, or transferring a listed 
agent or toxin commensurate with the risk such agent or toxin 
poses to public health and safety (including the risk of use 
in domestic or international terrorism). The Secretary shall 
establish such requirements in consultation with the Attorney 
General, and shall ensure compliance with such requirements 
as part of the registration system under such regulations. 
"(2) LIMITING ACCESS TO LISTED AGENTS AND TOXINS.— 
Requirements under paragraph (1) shall include provisions to 
ensure that registered persons— 
"(A) provide access to listed agents and toxins to only 
those individuals whom the registered person involved 
determines have a legitimate need to handle or use such 
agents and toxins; 
"(B) submit the names and other identifying informa-
tion for such individuals to the Secretary and the Attorney 
General, promptly after first determining that the individ-
uals need access under subparagraph (A), and periodically 
thereafter while the individuals have such access, not less 
frequently than once every five years; 
"(C) deny access to such agents and toxins by individ-
uals whom the Attorney General has identified as restricted 
persons; and 
"(D) limit or deny access to such agents and toxins 
by individuals whom the Attorney General has identified 
as within any category under paragraph (3)(B)(ii), if lim-
iting or denying such access by the individuals involved 
is determined appropriate by the Secretary, in consultation 
with the Attorney General. 
"(3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY 
GENERAL.— 
"(A) IN GENERAL.—^Upon the receipt of names and other 
identifying 
information 
under 
paragraph 
(2)(B), the 
Attorney General shall, for the sole purpose of identifying 
whether the individuals involved are within any of the 
categories specified in subparagraph (B), promptly use 
criminal, immigration, national security, and other elec-
tronic databases that are available to the Federal Govern-
ment and are appropriate for such purpose. 
"(B) CERTAIN INDIVIDUALS.—For purposes of subpara-
graph (A), the categories specified in this subparagraph 
regarding an individual are that— 
"(i) the individual is a restricted person; or 
"(ii) the individual is reasonably suspected by any 
Federal law enforcement or intelligence agency of— 
"(I) committing a crime set forth in section 
2332b(g)(5) of title 18, United States Code; 
116 STAT. 640 
PUBLIC LAW 107-188-^UNE 12, 2002 
"(II) knowing involvement with an organiza-
tion that engages in domestic or international ter-
rorism (as defined in section 2331 of such title 
18) or with any other organization that engages 
in intentional crimes of violence; or 
"(III) being an agent of a foreign power (as 
defined in section 1801 of title 50, United States 
Code). 
"(C) NOTIFICATION BY ATTORNEY GENERAL REGARDING 
SUBMITTED NAMES.—After the receipt of a name and other 
identifying 
information 
under 
paragraph 
(2)(B), 
the 
Attorney General shall promptly notify the Secretary 
whether the individual is within any of the categories 
specified in subparagraph (B). 
"(4) NOTIFICATIONS BY SECRETARY.—The Secretary, after 
receiving notice under paragraph (3) regarding an individual, 
shall promptly notify the registered person involved of whether 
the individual is granted or denied access under paragraph 
(2). If the individual is denied such access, the Secretary shall 
promptly notify the individual of the denial. 
"(5) EXPEDITED REVIEW.—Regulations under subsections (b) 
and (c) shall provide for a procedure through which, upon 
request to the Secretary by a registered person who submits 
names and other identifying information under paragraph 
(2)(B) and who demonstrates good cause, the Secretary may, 
as determined appropriate by the Secretary— 
"(A) request the Attorney General to expedite the 
process of identification 
under paragraph (3)(A) and 
notification of the Secretary under paragraph (3)(C); and 
"(B) expedite the notification of the registered person 
by the Secretary under paragraph (4). 
"(6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.— 
"(A) INDIVIDUALS.—Regulations under subsections (b) 
and (c) shall provide that an individual who seeks to reg-
ister under either of such subsections is subject to the 
same processes described in paragraphs (2) through (4) 
as apply to names and other identifying information sub-
mitted to the Attorney General under paragraph (2)(B). 
Paragraph (5) does not apply for purposes of this subpara-
graph. 
"(B) OTHER PERSONS.—Regulations under subsections 
(b) and (c) shall provide that, in determining whether to 
deny or revoke registration by a person other than an 
individual, the Secretary shall submit the name of such 
person to the Attorney General, who shall use criminal, 
immigration, national security, and other electronic data-
bases available to the Federal Government, as appropriate 
for the purpose of promptly notifying the Secretary whether 
the person, or, where relevant, the individual who owns 
or controls such person, is a restricted person or is reason-
ably suspected by any Federal law enforcement or intel-
ligence agency of being within any category specified in 
paragraph (3)(B)(ii) (as applied to persons, including 
individuals). Such regulations shall provide that a person 
who seeks to register under either of such subsections 
is subject to the same processes described in paragraphs 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 641 
(2) and (4) as apply to names and other identifying informa-
tion submitted to the Attorney General under paragraph 
(2)(B). Paragraph (5) does not apply for purposes of this 
subparagraph. The Secretary may exempt Federal, State, 
or local governmental agencies from the requirements of 
this subparagraph. 
"(7) REVIEW.— 
"(A) ADMINISTRATIVE REVIEW.— 
"(i) IN GENERAL.—Regulations under subsections 
(b) and (c) shall provide for an opportunity for a review 
by the Secretary— 
"(I) when requested by the individual involved, 
of a determination under paragraph (2) to deny 
the individual access to listed agents and toxins; 
and 
"(II) when requested by the person involved, 
of a determination under paragraph (6) to deny 
or revoke registration for such person. 
"(ii) Ex PARTE REVIEW.—During a review under 
clause (i), the Secretary may consider information rel-
evant to the review ex parte to the extent that disclo-
sure of the information could compromise national 
security or an investigation by any law enforcement 
agency. 
"(iii) FINAL AGENCY ACTION.—The decision of the 
Secretary in a review under clause (i) constitutes final 
agency action for purposes of section 702 of title 5, 
United States Code. 
"(B) CERTAIN PROCEDURES.— 
"(i) 
SUBMISSION 
OF EX PARTE 
MATERIALS IN 
JUDICIAL PROCEEDINGS.—^When reviewing a decision of 
the Secretary under subparagraph (A), and upon 
request made ex parte and in writing by the United 
States, a court, upon a sufficient showing, may review 
and consider ex parte documents containing informa-
tion the disclosure of which could compromise national 
security or an investigation by any law enforcement 
agency. If the court determines that portions of the 
documents considered ex parte should be disclosed to 
the person involved to allow a response, the court 
shall authorize the United States to delete from such 
documents specified items of information the disclosure 
of which could compromise national security or an 
investigation by any law enforcement agency, or to 
substitute a summary of the information to which the 
person may respond. Any order by the court author-
izing the disclosure of information that the United 
States believes could compromise national security or 
an investigation by any law enforcement agency shall 
be subject to the processes set forth in subparagraphs 
(A) and (B)(i) of section 2339B(f)(5) of title 18, United 
States Code (relating to interlocutory appeal and expe-
dited consideration). 
"(ii) DISCLOSURE OF INFORMATION.—In a review 
under subparagraph (A), and in any judical proceeding 
conducted pursuant to such review, neither the Sec-
retary nor the Attorney General may be required to 
116 STAT. 642 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
disclose to the public any information that under sub-
section (h) shall not be disclosed under section 552 
of title 5, United States Code. 
"(8) NOTIFICATIONS REGARDING THEFT OR LOSS OF AGENTS.— 
Requirements under paragraph (1) shall include the prompt 
notification of the Secretary, and appropriate Federal, State, 
and local law enforcement agencies, of the theft or loss of 
listed agents and toxins. 
"(9) TECHNICAL ASSISTANCE FOR REGISTERED PERSONS.— 
The Secretary, in consultation with the Attorney General, may 
provide technical assistance to registered persons to improve 
security of the facilities of such persons. 
"(f) INSPECTIONS.—The Secretary shall have the authority to 
inspect persons subject to regulations under subsection (b) or (c) 
to ensure their compliance with such regulations, including prohibi-
tions on restricted persons and other provisions of subsection (e). 
"(g) EXEMPTIONS.— 
"(1) CLINICAL OR DIAGNOSTIC LABORATORIES.—Regulations 
under subsections (b) and (c) shall exempt clinical or diagnostic 
laboratories and other persons who possess, use, or transfer 
listed agents or toxins that are contained in specimens pre-
sented for diagnosis, verification, or proficiency testing, pro-
vided that— 
"(A) the identification of such agents or toxins is 
reported to the Secretary, and when required under Fed-
eral, State, or local law, to other appropriate authorities; 
and 
"(B) such agents or toxins are transferred or destroyed 
in a manner set forth by the Secretary by regulation. 
"(2) PRODUCTS.— 
"(A) IN GENERAL.—^Regulations under subsections (b) 
and (c) shall exempt products that are, bear, or contain 
listed agents or toxins and are cleared, approved, licensed, 
or registered under any of the Acts specified in subpara-
graph (B), unless the Secretary by order determines that 
applying additional regulation under subsection (b) or (c) 
to a specific product is necessary to protect public health 
and safety. 
"(B) RELEVANT LAWS.—^For purposes of subparagraph 
(A), the Acts specified in this subparagraph are the fol-
lowing: 
"(i) The Federal Food, Drug, and Cosmetic Act. 
"(ii) Section 351 of this Act. 
"(iii) The Act commonly known as the Virus-
Serum-Toxin Act (the eighth paragraph under the 
heading 'Bureau of Animal Industry' in the Act of 
March 4, 1913; 21 U.S.C. 151-159). 
"(iv) The Federal Insecticide, Fungicide, 
and 
Rodenticide Act. 
"(C) INVESTIGATIONAL USE.— 
"(i) IN GENERAL.—^The Secretary may exempt an 
investigational product that is, bears, or contains a 
listed agent or toxin from the applicability of provisions 
of regulations under subsection (b) or (c) when such 
product is being used in an investigation authorized 
under any Federal Act and the Secretary determines 
that applying additional regulation under subsection 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
116 STAT. 643 
(b) or (c) to such product is not necessary to protect 
public health and safety. 
"(ii) CERTAIN PROCESSES.—Regulations under sub-
sections (b) and (c) shall set forth the procedures for 
applying for an exemption under clause (i). In the Deadline. 
case of investigational products authorized under any 
of the Acts specified in subparagraph (B), the Secretary 
shall make a determination regarding a request for 
an exemption not later than 14 days after the first 
date on which both of the following conditions have 
been met by the person requesting the exemption: 
"(I) The person has submitted to the Secretary 
an application for the exemption meeting the 
requirements established by the Secretary. 
"(II) The person has notified the Secretary 
that the investigation has been authorized under 
such an Act. 
"(3) PUBLIC HEALTH EMERGENCIES.—The Secretary may 
temporarily exempt a person from the applicability of the 
requirements of this section, in whole or in part, if the Secretary 
determines that such exemption is necessary to provide for 
the timely participation of the person in a response to a 
domestic or foreign public health emergency (whether deter-
mined under section 319(a) or otherwise) that involves a listed 
agent or toxin. With respect to the emergency involved, such 
exemption for a person may not exceed 30 days, except that 
the Secretary, after review of whether such exemption remains 
necessary, may provide one extension of an additional 30 days. 
"(4) AGRICULTURAL EMERGENCIES.—Upon request of the 
Secretary of Agriculture, after the granting by such Secretary 
of an exemption under section 212(g)(1)(D) of the Agricultural 
Bioterrorism Protection Act of 2002 pursuant to a finding that 
there is an agricultural emergency, the Secretary of Health 
£ind Human Services may temporarily exempt a person from 
the applicability of the requirements of this section, in whole 
or in part, to provide for the timely participation of the person 
in a response to the agricultural emergency. With respect to 
the emergency involved, the exemption under this paragraph 
for a person may not exceed 30 days, except that upon request 
of the Secretary of Agriculture, the Secretary of Health and 
Human Services may, after review of whether such exemption 
remains necessary, provide one extension of an additional 30 
days. 
"(h) DISCLOSURE OF INFORMATION.— 
"(1) NONDISCLOSURE OF CERTAIN INFORMATION.—^No Fed-
eral agency specified in paragraph (2) shall disclose under 
section 552 of title 5, United States Code, any of the following: 
"(A) Any registration or transfer documentation sub-
mitted under subsections (b) and (c) for the possession, 
use, or transfer of a listed agent or toxin; or information 
derived therefrom to the extent that it identifies the listed 
agent or toxin possessed, used, or transferred by a specific 
registered person or discloses the identity or location of 
a specific registered person. 
"(B) The national database developed pursuant to sub-
section (d), or any other compilation of the registration 
or transfer information submitted under subsections (b) 
116 STAT. 644 
PUBLIC LAW 1 0 7 - 1 8 8 - J U N E 12, 2002 
and (c) to the extent that such compilation discloses site-
specific registration or transfer information. 
"(C) Any portion of a record that discloses the site-
specific or transfer-specific safeguard and security meas-
ures used by a registered person to prevent unauthorized 
access to listed agents and toxins. 
"(D) Any notification of a release of a listed agent 
or toxin submitted imder subsections (b) and (c), or any 
notification of theft or loss submitted under such sub-
sections. 
"(E) Any portion of an evaluation or report of an inspec-
tion of a specific registered person conducted under sub-
section (f) that identifies the listed agent or toxin possessed 
by a specific registered person or that discloses the identity 
or location of a specific registered person if the agency 
determines that public disclosure of the information would 
endanger public health or safety. 
"(2) COVERED AGENCIES.—For purposes of paragraph (1) 
only, the Federal agencies specified in this paragraph are the 
following: 
"(A) The Department of Health and Human Services, 
the Department of Justice, the Department of Agriculture, 
and the Department of Transportation. 
"(B) Any Federal agency to which information specified 
in paragraph (1) is transferred by any agency specified 
in subparagraph (A) of this paragraph. 
"(C) Any Federal agency that is a registered person, 
or has a sub-agency component that is a registered person. 
"(D) Any Federal agency that awards grants or enters 
into contracts or cooperative agreements involving listed 
agents and toxins to or with a registered person, and 
to which information specified in paragraph (1) is trans-
ferred by any such registered person. 
"(3) OTHER EXEMPTIONS.—This subsection may not be con-
strued as altering the application of any exemptions to public 
disclosure under section 552 of title 5, United States Code, 
except as to subsection 552(b)(3) of such title, to any of the 
information specified in paragraph (1). 
"(4) RULE OF CONSTRUCTION.—Except as specifically pro-
vided in paragraph (1), this subsection may not be construed 
as altering the authority of any Federal agency to withhold 
under section 552 of title 5, United States Code, or the obliga-
tion of any Federal agency to disclose under section 552 of 
title 5, United States Code, any information, including informa-
tion relating to— 
"(A) listed agents and toxins, or individuals seeking 
access to such agents and toxins; 
"(B) registered persons, or persons seeking to register 
their possession, use, or transfer of such agents and toxins; 
"(C) general safeguard and security policies and 
requirements under regulations under subsections (b) and 
(c); or 
"(D) summary or statistical information concerning reg-
istrations, registrants, denials or revocations of registra-
tions, listed agents and toxins, inspection evaluations and 
reports, or individuals seeking access to such agents and 
toxins. 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 645 
"(5) DISCLOSURES TO CONGRESS; OTHER DISCLOSURES.—This 
subsection may not be construed as providing any authority— 
"(A) to withhold information from the Congress or any 
committee or subcommittee thereof; or 
"(B) to withhold information from any person under 
any other Federal law or treaty, 
"(i) CIVIL MONEY PENALTY.— 
"(1) IN GENERAL.—In addition to any other penalties that 
may apply under law, any person who violates any provision 
of regulations under subsection (b) or (c) shall be subject to 
the United States for a civil money penalty in an amount 
not exceeding $250,000 in the case of an individual and 
$500,000 in the case of any other person. 
"(2) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions 
of section 1128A of the Social Security Act (other than sub-
sections (a), (b), (h), and (i), the first sentence of subsection 
(c), and paragraphs (1) and (2) of subsection (f)) shall apply 
to a civil money penalty under paragraph (1) in the same 
manner as such provisions apply to a penalty or proceeding 
under section 1128A(a) of such Act. The Secretary may delegate 
authority under this subsection in the same manner as provided 
in section 1128A(j)(2) of the Social Security Act, and such 
authority shall include all powers as contained in section 6 
of the Inspector General Act of 1978 (5 U.S.C. App.). 
"(j) NOTIFICATION IN EVENT OF RELEASE.—Regulations under 
subsections (b) and (c) shall require the prompt notification of 
the Secretary by a registered person whenever a release, meeting 
criteria established by the Secretary, of a listed agent or toxin 
has occurred outside of the biocontainment area of a facility of 
the registered person. Upon receipt of such notification and a finding 
by the Secretary that the release poses a threat to public health 
or safety, the Secretary shall take appropriate action to notify " 
relevant State and local public health authorities, other relevant 
Federal authorities, and, if necessary, other appropriate persons 
(including the public). If the released listed agent or toxin is an 
overlap agent or toxin (as defined in subsection (1)), the Secretary 
shall promptly notify the Secretary of Agriculture upon notification 
by the registered person. 
"(k) REPORTS.—The Secretary shall report to the Congress 
annually on the number and nature of notifications received under 
subsection (e)(8) (relating to theft or loss) and subsection (j) (relating 
to releases). 
"(1) DEFINITIONS.—For purposes of this section: 
"(1) The terms 'biological agent' and 'toxin' have the 
meanings given such terms in section 178 of title 18, United 
States Code. 
"(2) The term 'listed agents and toxins' means biological 
agents and toxins listed pursuant to subsection (a)(1). 
"(3) The term 'listed agents or toxins' means biological 
agents or toxins listed pursuant to subsection (a)(1). 
"(4) The term 'overlap agents and toxins' means biological 
agents and toxins that— 
"(A) are listed pursuant to subsection (a)(1); and 
"(B) are listed pursuant to section 212(a)(1) of the 
Agricultural Bioterrorism Protection Act of 2002. 
"(5) The term 'overlap agent or toxin' means a biological 
agent or toxin that— 
116 STAT. 646 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
Deadline. 
42 u s e 262a 
note. 
Deadlines. 
42 u s e 262a 
note. 
Guidelines. 
Rules. 
"(A) is listed pursuant to subsection (a)(1); and 
"(B) is listed pursuant to section 212(a)(1) of the Agri-
cultural Bioterrorism Protection Act of 2002. 
"(6) The term 'person' includes Federal, State, and local 
governmental entities. 
"(7) The term 'registered person' means a person registered 
under regulations under subsection (b) or (c). 
"(8) The term 'restricted person' has the meaning given 
such term in section 175b of title 18, United States Code. 
"(m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
such sums as may be necessary for each of the fiscal years 2002 
through 2007.". 
(b) REPORT TO CONGRESS.—Not later than one 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 regula-
tions under section 35lA of the Public Health Service Act 
(as added by subsection (a) of this section), including the extent 
of compliance before the date of the enactment of this Act, 
and including the extent of compliance with regulations promul-
gated after such date of enactment; 
(2) describes the actions to date and future plans of the 
Secretary for updating the list of biological agents and toxins 
under such section 35lA; 
(3) describes the actions to date and future plans of the 
Secretary for determining compliance with regulations under 
such section 35 lA and for taking appropriate enforcement 
actions; 
(4) evaluates the impact of such section 35 lA on research 
on biological agents and toxins listed pursuant to such section; 
and 
(5) provides any recommendations of the Secretary for 
administrative or legislative initiatives regarding such section 
35 l A 
SEC. 
202. 
IMPLEMENTATION 
BY 
DEPARTMENT 
OF 
HEALTH 
AND 
HUMAN 
SERVICES. 
(a) DATE CERTAIN FOR NOTICE OF POSSESSION.—Not later than 
90 days after the date of the enactment of this Act, all persons 
(unless exempt under subsection (g) of section 35 lA of the Public 
Health Service Act, as added by section 201 of this Act) in possession 
of biological agents or toxins listed under such section 351A of 
the Public Health Service Act shall notify the Secretary of Health 
and Human Services of such possession. Not later than 30 days 
after such date of enactment, the Secretary shall provide written 
guidance on how such notice is to be provided to the Secretary. 
(b) 
DATE 
CERTAIN FOR 
PROMULGATION; EFFECTIVE 
DATE 
REGARDING CRIMINAL AND CIVIL PENALTIES.—Not later than 180 
days after the date of the enactment of this Act, the Secretary 
of Health and Human Services shall promulgate an interim final 
rule for carrying out section 35 lA of the Public Health Service 
Act, subject to subsection (c). Such interim final rule shall take 
effect 60 days after the date on which such rule is promulgated, 
including for purposes o
f
— 
PUBLIC LAW 1 0 7 - 1 8 8 - J U N E 12, 2002 
116 STAT. 647 
(1) section 175b(c) of title 18, United States Code (relating 
to criminal penalties), as added by section 231(a)(5) of this 
Act; and 
(2) section 351A(i) of the Public Health Service Act (relating 
to civil penalties). 
(c) TRANSITIONAL PROVISION REGARDING CURRENT RESEARCH 
AND EDUCATION.—^The interim final rule under subsection (b) shall 
include time frames for the applicability of the rule that minimize 
disruption of research or educational projects that involve biological 
agents and toxins listed pursuant to section 351A(a)(l) of the Public 
Health Service Act and that were underway as of the effective 
date of such rule. 
SEC. 203. EFFECTIVE DATES. 
42 USC 262a 
(a) IN GENERAL.—^Regulations promulgated by the Secretary 
of Health 
and Human 
Services under 
section 511 of the 
Antiterrorism and Effective Death Penalty Act of 1996 are deemed 
to have been promulgated under section 35 lA of the Public Health 
Service Act, as added by section 201 of this Act. Such regulations, 
including the list under subsection (d)(1) of such section 511, that 
were in effect on the day before the date of the enactment of 
this Act remain in effect until modified by the Secretary in accord-
ance with such section 35 lA and with section 202 of this Act. 
(b) 
EFFECTIVE DATE REGARDING DISCLOSURE OF INFORMA-
TION.—Subsection (h) of section 35 lA of the Public Health Service 
Act, as added by section 201 of this Act, is deemed to have taken 
effect on the effective date of the Antiterrorism and Effective Death 
Penalty Act of 1996. 
SEC. 204. 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. 
Subtitle B—Department of Agriculture 
A
g
r
i
c
u
l
t
u
r
a
l 
Bioterrorism 
Protection Act of 
SEC. 211. SHORT TITLE. 
2002. 
This subtitle may be cited as the "Agricultural Bioterrorism 
Protection Act of 2002". 
7 USC 8401 note. 
SEC. 212. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS. 
7 USC 8401. 
(a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS AND 
TOXINS.— 
(1) LIST OF BIOLOGICAL AGENTS AND TOXINS.— 
(A) IN GENERAL.—The Secretary of Agriculture shall 
by regulation establish and maintain a list of each 
biological agent Eind each toxin that the Secretary deter-
mines has the potential to pose a severe threat to animal 
or plant health, or to animal or plant products. 
(B) CRITERIA.—In determining whether to include an 
agent or toxin on the list under subparagraph (A), the 
Secretary shsill— 
(i) consider— 
(I) the effect of exposure to the agent or toxin 
on animal or plant health, and on the production 
and marketability of animal or plant products; 
99-194 O - 03 - 22 : QL 3 Part 1 
116 STAT. 648 
PUBLIC LAW 107-188-^UNE 12, 2002 
(II) the pathogenicity of the agent or the tox-
icity of the toxin and the methods by which the 
agent or toxin is transferred to animals or plants; 
(III) the availability and effectiveness 
of 
pharmacotherapies and prophylaxis to treat and 
prevent smy illness caused by the agent or toxin; 
and 
(IV) any other criteria that the Secretary con-
siders appropriate to protect animal or plant 
health, or animal or plant products; and 
(ii) consult with appropriate Federal departments 
and agencies and with scientific experts representing 
appropriate professional groups. 
Publication. 
(2) BIENNIAL REVIEW.—The Secretary shall review and 
repul;i;lish the list under paragraph (1) biennially, or more often 
as needed, and shall by regulation revise the list as necessary 
in accordance with such paragraph. 
Safety. 
(b) REGULATION OF TRANSFERS OF LISTED AGENTS AND 
TOXINS.—The Secretary shall by regulation provide for— 
(1) the establishment and enforcement of safety procedures 
for the transfer of listed agents and toxins, including measures 
to ensure— 
(A) proper training and appropriate skills to handle 
such agents and toxins; and 
(B) proper laboratory facilities to contain and dispose 
of such agents and toxins; 
(2) the establishment and enforcement of safeguard and 
security measures to prevent access to such agents and toxins 
for use in domestic or international terrorism or for Einy other 
criminal purpose; 
(3) the establishment of procedures to protect animal and 
plant health, and animal and plant products, in the event 
of a transfer or potential transfer of such an agent or toxin 
in violation of the safety procedures established under para-
graph (1) or the safeguard and security measures established 
under paragraph (2); and 
(4) appropriate availability of biological agents and toxins 
for research, education, and other legitimate purposes. 
(c) POSSESSION AND USE OF LISTED AGENTS AND TOXINS.— 
The Secretary shall by regulation provide for the establishment 
and enforcement of standards and procedures governing the posses-
sion and use of listed agents and toxins, including the provisions 
described in paragraphs (1) through (4) of subsection (b), in order 
to protect animal and plant health, and animal and plant products. 
(d) REGISTRATION; IDENTIFICATION; DATABASE.— 
(1) REGISTRATION.—Regulations under subsections (b) and 
(c) shall require registration with the Secretary of the posses-
sion, use, and transfer of listed agents and toxins, and shall 
include provisions to ensure that persons seeking to register 
under such regulations have a lawful purpose to possess, use, 
or transfer such agents and toxins, including provisions in 
accordance with subsection (e)(6). 
(2) IDENTIFICATION; DATABASE.—Regulations under sub-
sections (b) and (c) shall require that registration include (if 
available to the person registering) information regarding the 
characterization of listed agents and toxins to facilitate their 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 649 
identification, including their source. The Secretary shall main- Records, 
tain a national database that includes the names and locations 
of registered persons, the listed agents and toxins such persons 
are 
possessing, 
using, 
or transferring, 
and 
information 
regarding the characterization of such agents and toxins, 
(e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REGISTERED 
PERSONS.— 
(1) IN GENERAL.—^Regulations under subsections (b) and 
(c) shall include appropriate safeguard and security require-
ments for persons possessing, using, or transferring a listed 
agent or toxin commensurate with the risk such agent or toxin 
poses to animal and plant health, and animal and plant prod-
ucts (including the risk of use in domestic or international 
terrorism). The Secretary shall establish such requirements 
in consultation with the Attorney General, and shall ensure 
compliance with such requirements as part of the registration 
system under such regulations. 
(2) 
LIMITING ACCESS TO LISTED AGENTS AND TOXINS.— 
Requirements under paragraph (1) shall include provisions to 
ensure that registered persons— 
(A) provide access to listed agents and toxins to only 
those individuals whom the registered person involved 
determines have a legitimate need to handle or use such 
agents and toxins; 
(B) submit the names and other identifying information 
for such individuals to the Secretary and the Attorney 
General, promptly after first determining that the individ-
uals need access under subparagraph (A), and periodically 
thereafter while the individuals have such access, not less 
frequently than once every five years; and 
(C)(i) in the case of listed agents and toxins that are 
not overlap agents and toxins (as defined in subsection 
(g)(l)(A)(ii)), limit or deny access to such agents and toxins 
by individuals whom the Attorney General has identified 
as within any category under paragraph (3)(B), if limiting 
or denying such access by the individuals involved is deter-
mined appropriate by the Secretary, in consultation with 
the Attorney General; and 
(ii) in the case of listed agents and toxins that are 
overlap agents— 
(I) deny access to such agents and toxins by 
individuals whom the Attorney General has identi-
fied as within any category referred to in para-
graph (3)(B)(i); and 
(II) limit or deny access to such agents and 
toxins by individuals whom the Attorney General 
has identified as within any category under para-
graph (3)(B)(ii), if limiting or denying such access 
by the individuals involved is determined appro-
priate by the Secretary, in consultation with the 
Attorney General. 
(3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY 
GENERAL.— 
(A) IN GENERAL.—^Upon the receipt of names and other 
identifying 
information 
under 
paragraph 
(2)(B), 
the 
Attorney General shall, for the sole purpose of identifying 
whether the individuals involved are within any of the 
116 STAT. 650 
PUBLIC LAW 107-188^TUNE 12, 2002 
categories specified in subparagraph (B), promptly use 
criminal, immigration, national security, and other elec-
tronic databases that are available to the Federal Govern-
ment and are appropriate for such purpose. 
(B) CERTAIN INDIVIDUALS.—^For purposes of subpara-
graph (A), the categories specified in this subparagraph 
regarding an individual are that— 
(i) the individual is within any of the categories 
described in section 175b(dXl) of title 18, United States 
Code (relating to restricted persons); or 
(ii) the individual is reasonably suspected by any 
Federal law enforcement or intelligence agency of— 
(I) committing a crime set forth in section 
2332b(g)(5) of title 18, United States Code; 
(II) knowing involvement with an organization 
that engages in domestic or international terrorism 
(as defined in section 2331 of such title 18) or 
with any other organization that engages in inten-
tional crimes of violence; or 
(III) being an agent of a foreign power (as 
defined in section 1801 of title 50, United States 
Code). 
(C) NOTIFICATION BY ATTORNEY GENERAL REGARDING 
SUBMITTED NAMES.—^After the receipt of a name and other 
identifying 
information 
under 
paragraph 
(2)(B), the 
Attorney General shall promptly notify the Secretary 
whether the individual is within any of the categories 
specified in subparagraph (B). 
(4) NOTIFICATIONS BY SECRETARY.—^The Secretary, after 
receiving notice under paragraph (3) regarding an individual, 
shall promptly notify the registered person involved of whether 
the individual is granted or denied access under paragraph 
(2). If the individual is denied such access, the Secretary shall 
promptly notify the individual of the denial. 
(5) EXPEDITED REVIEW.—Regulations under subsections (b) 
and (c) shall provide for a procedure through which, upon 
request to the Secretary by a registered person who submits 
names and other identifying information under paragraph 
(2)(B) and who demonstrates good cause, the Secretary may, 
as determined appropriate by the Secretary— 
(A) request the Attorney General to expedite the 
process of identification 
under paragraph (3)(A) and 
notification of the Secretary under paragraph (3)(C); and 
(B) expedite the notification of the registered person 
by the Secretary under paragraph (4). 
(6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.— 
(A) INDIVIDUALS.—^Regulations under subsections (b) 
and (c) shall provide that an individual who seeks to reg-
ister under either of such subsections is subject to the 
same processes described in paragraphs (2) through (4) 
as apply to names and other identifying information sub-
mitted to the Attorney General under paragraph (2)(B). 
Paragraph (5) does not apply for purposes of this subpara-
graph. 
(B) OTHER PERSONS.—Regulations under subsections 
(b) and (c) shall provide that, in determining whether to 
deny or revoke registration by a person other than an 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 651 
individual, the Secretary shall submit the name of such 
person to the Attorney General, who shall use criminal, 
immigration, national security, and other electronic data-
bases available to the Federal Government, as appropriate 
for the purpose of promptly notifying the Secretary whether 
the person, or, where relevant, the individual who owns 
or controls such person, is within any of the categories 
described in section 175b(d)(l) of title 18, United States 
Code (relating to restricted persons), or is reasonably sus-
pected by any Federal law enforcement or intelligence 
agency of being within any category specified in paragraph 
(3)(B)(ii) (as applied to persons, including individuals). Such 
regulations shall provide that a person who seeks to reg-
ister under either of such subsections is subject to the 
same processes described in paragraphs (2) and (4) as 
apply to names and other identifying information submitted 
to the Attorney General under paragraph (2)(B). Paragraph 
(5) does not apply for purposes of this subparagraph. The 
Secretary may exempt Federal, State, or local governmental 
agencies from the requirements of this subparagraph. 
(7) REVIEW.— 
(A) ADMINISTRATIVE REVIEW.— 
(i) IN GENERAL.—Regulations under subsections (b) 
and (c) shall provide for an opportunity for a review 
by the Secretary— 
(I) when requested by the individual involved, 
of a determination under paragraph (2) to deny 
the individual access to listed agents and toxins; 
and 
(II) when requested by the person involved, 
of a determination under under paragraph (6) to 
deny or revoke registration for such person. 
(ii) Ex PARTE REVIEW.—^During a review under 
clause (i), the Secretary may consider information rel-
evant to the review ex parte to the extent that disclo-
sure of the information could compromise national 
security or an investigation by any law enforcement 
agency. 
(iii) FINAL AGENCY ACTION.—The decision of 
the 
Secretary in a review under clause (i) constitutes final 
agency action for purposes of section 702 of title 5, 
United States Code. 
(B) CERTAIN PROCEDURES.— 
(i) SUBMISSION OF EX PARTE MATERIALS IN JUDICIAL 
PROCEEDINGS.—^When reviewing a decision of the Sec-
retary under subparagraph (A), and upon request made 
ex parte and in writing by the United States, a court, 
upon a sufficient showing, may review and consider 
ex parte documents containing information the disclo-
sure of which could compromise national security or 
an investigation by any law enforcement agency. If 
the court determines that portions of the documents 
considered ex parte should be disclosed to the person 
involved to allow a response, the court shall authorize 
the United States to delete from such documents speci-
fied items of information the disclosure of which could 
compromise national security or an investigation by 
116 STAT. 652 
PUBLIC LAW 1 0 7 - 1 8 8 - J U N E 12, 2002 
any law enforcement agency, or to substitute a sum-
mary of the information to which the person may 
respond. Any order by the court authorizing the disclo-
sure of information that the United States believes 
could compromise national security or an investigation 
by any law enforcement agency shall be subject to 
the processes set forth in subparagraphs (A) and (B)(i) 
of section 2339B(f)(5) of title 18, United States Code 
(relating to interlocutory appeal and expedited consid-
eration). 
(ii) DISCLOSURE OF INFORMATION.—In a review 
under subparagraph (A), and in any judical proceeding 
conducted pursuant to such review, neither the Sec-
retary nor the Attorney General may be required to 
disclose to the public any information that under sub-
section (h) shall not be disclosed under section 552 
of title 5, United States Code. 
(8) NOTIFICATIONS REGARDING THEFT OR LOSS OF AGENTS.— 
Requirements under paragraph (1) shall include the prompt 
notification of the Secretary, and appropriate Federal, State, 
and local law enforcement agencies, of the theft or loss of 
listed agents and toxins. 
(9) TECHNICAL ASSISTANCE FOR REGISTERED PERSONS.—The 
Secretary, in consultation with the Attorney General, may pro-
vide technical assistance to registered persons to improve secu-
rity of the facilities of such persons. 
(f) INSPECTIONS.—^The Secretary shall have the authority to 
inspect persons subject to regulations under subsection (b) or (c) 
to ensure their compliance with such regulations, including prohibi-
tions on restricted persons and other provisions of subsection (e). 
(g) EXEMPTIONS.— 
(1) OVERLAP AGENTS AND TOXINS.— 
(A) IN GENERAL.— 
(i) LIMITATION.—In the case of overlap agents and 
toxins, exemptions from the applicability of provisions 
of regulations under subsection (b) or (c) may be 
granted only to the extent provided in this paragraph. 
(ii) DEFINITIONS.—For purposes of this section: 
(I) The term "overlap agents and toxins" 
means biological agents and toxins that— 
(aa) are listed pursuant to subsection 
(a)(1); and 
(bb) 
are 
listed 
pursuant 
to 
section 
315A(a)(l) of the Public Health Service Act. 
(II) The term "overlap agent or toxin" means 
a biological agent or toxin that— 
(aa) is listed pursuant to subsection (a)(1); 
and 
(bb) 
is 
listed 
pursuant 
to 
section 
315A(a)(l) of the Public Health Service Act. 
(B) CLINICAL OR DIAGNOSTIC LABORATORIES.—Regula-
tions under subsections (b) and (c) shall exempt clinical 
or diagnostic laboratories and other persons who possess, 
use, or transfer overlap agents or toxins that are contained 
in specimens presented for diagnosis, verification, or pro-
ficiency testing, provided that— 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
116 STAT. 653 
(i) the identification of such agents or toxins is 
reported to the Secretary, and when required under 
Federal, State, or local law, to other appropriate 
authorities; and 
(ii) such agents or toxins are transferred or 
destroyed in a manner set forth by the Secretary by 
regulation. 
(C) PRODUCTS.— 
(i) IN GENERAL.—^Regulations under subsections (b) 
and (c) shall exempt products that are, bear, or contain 
overlap agents or toxins and are cleared, approved, 
licensed, or registered under any of the Acts specified 
in clause (ii), unless the Secretary by order determines 
that applying additional regulation under subsection 
(b) or (c) to a specific product is necessary to protect 
animal or plant health, or animal or plant products. 
(ii) RELEVANT LAWS.—^For purposes of clause (i), 
the Acts specified in this clause are the following: 
(I) The Federal Food, Drug, and Cosmetic Act. 
(II) Section 351 of the Public Health Service 
Act. 
(III) The Act commonly known as the Virus-
Serum-Toxin Act (the eighth paragraph under the 
heading "Bureau of Animal Industry" in the Act 
of March 4, 1913; 21 U.S.C. 151-159). 
(IV) The Federal Insecticide, Fungicide, and 
Rodenticide Act. 
(iii) INVESTIGATIONAL USE.— 
(I) IN GENERAL.—The Secretary may exempt 
an investigational product that is, bears, or con-
tains an overlap agent or toxin from the applica-
bility of provisions of regulations under subsection 
(b) or (c) when such product is being used in an 
investigation authorized under any Federal Act 
and the Secretary determines that applying addi-
tional regulation under subsection (b) or (c) to 
such product is not necessary to protect animal 
and plant health, and animal and plant products. 
(II) CERTAIN PROCESSES.—Regulations under 
subsections (b) and (c) shall set forth the proce-
dures for applying for an exemption under sub-
clause (I). In the case of investigational products 
authorized under any of the Acts specified in clause 
(ii), the Secretary shall make a determination 
regarding a request for an exemption not later 
than 14 days after the first date on which both 
of the following conditions have been met by the 
person requesting the exemption: 
(aa) The person has submitted to the Sec-
retary 
an 
application 
for 
the 
exemption 
meeting the requirements established by the 
Secretary. 
(bb) The person has notified the Secretary 
that the investigation has been authorized 
under such an Act. 
(D) AGRICULTURAL EMERGENCIES.—The Secretary may 
temporarily exempt a person from the applicability of the 
116 STAT. 654 
PUBLIC LAW 107-188—JUNE 12, 2002 
requirements of this section with respect to an overlap 
agent or toxin, in whole or in part, if the Secretary deter-
mines that such exemption is necessary to provide for 
the timely participation of the person in a response to 
a domestic or foreign agricultural emergency that involves 
such an agent or toxin. With respect to the emergency 
involved, the exemption under this subparagraph for a 
person may not exceed 30 days, except that the Secretary, 
after review of whether such exemption remains necessary, 
may provide one extension of an additional 30 days. 
(E) PUBLIC HEALTH EMERGENCIES.—^Upon request of 
the Secretary of Health and Human Services, after the 
granting by such Secretary of an exemption 
under 
351A(gX3) of the Public Health Service Act pursuant to 
a finding that there is a public health emergency, the 
Secretary of Agriculture may temporarily exempt a person 
from the applicability of the requirements of this section 
with respect to an overlap agent or toxin, in whole or 
in part, to provide for the timely participation of the person 
in a response to the public health emergency. With respect 
to the emergency involved, such exemption for a person 
may not exceed 30 days, except that upon request of the 
Secretary of Health and Human Services, the Secretary 
of Agriculture may, after review of whether such exemption 
remains necessary, provide one extension of an additional 
30 days. 
(2) GENERAL AUTHORITY FOR EXEMPTIONS NOT INVOLVING 
OVERLAP AGENTS OR TOXINS.—In the case of listed agents or 
toxins that are not overlap agents or toxins, the Secretary 
may grant exemptions from the applicability of provisions of 
regulations under subsection (b) or (c) if the Secretary deter-
mines that such exemptions are consistent with protecting 
animal and plant health, and animal and plant products. 
(h) DISCLOSURE OF INFORMATION.— 
(1) NONDISCLOSURE OF CERTAIN INFORMATION.—No Federal 
agency specified in paragraph (2) shall disclose under section 
552 of title 5, United States Code, any of the following: 
(A) Any registration or transfer documentation sub-
mitted under subsections (b) and (c), or permits issued 
prior to the date of the enactment of this Act, for the 
possession, use or transfer of a listed agent or toxin; or 
information derived therefrom to the extent that it identi-
fies the listed agent or toxin possessed, used or transferred 
by a specific person or discloses the identity or location 
of a specific person. 
(B) The national database developed pursuant to sub-
section (d), or any other compilation of the registration 
or transfer information submitted under subsections (b) 
and (c) to the extent that such compilation discloses site-
specific registration or transfer information. 
(C) Any portion of a record that discloses the site-
specific or transfer-specific safeguard and security meas-
ures used by a registered person to prevent unauthorized 
access to listed agents and toxins. 
(D) Any notification of a release of a listed agent or 
toxin submitted under subsections (b) and (c), or any 
PUBLIC LAW 107-18&-^UNE 12, 2002 
116 STAT. 655 
notification of theft or loss submitted under such sub-
sections. 
(E) Any portion of an evaluation or report of an inspec-
tion of a specific registered person conducted under sub-
section (f) that identifies the listed agent or toxin possessed 
by a specific registered person or that discloses the identity 
or location of a specific registered person if the agency 
determines that public disclosure of the information would 
endanger animal or plant health, or animal or plant prod-
ucts. 
(2) COVERED AGENCIES.—For purposes of paragraph (1) 
only, the Federal agencies specified in this paragraph are the 
following: 
(A) 'Hie Department of Health and Human Services, 
the Department of Justice, the Department of Agriculture, 
and the Department of Transportation. 
(B) Any Federal agency to which information specified 
in paragraph (1) is transferred by any agency specified 
in subparagraph (A) of this paragraph. 
(C) Any Federal agency that is a registered person, 
or has a sub-agency component that is a registered person. 
(D) Any Federal agency that awards grants or enters 
into contracts or cooperative agreements involving listed 
agents and toxins to or with a registered person, and 
to which information specified in paragraph (1) is trans-
ferred by any such registered person. 
(3) OTHER EXEMPTIONS.—This subsection may not be con-
strued as altering the application of any exemptions to public 
disclosure under section 552 of title 5, United States Code, 
except as to subsection 552(b)(3) of such title, to any of the 
information specified in paragraph (1). 
(4) RULE OF CONSTRUCTION.—^Except as specifically pro-
vided in paragraph (1), this subsection may not be construed 
as altering the authority of any Federal agency to withhold 
under section 552 of title 5, United States Code, or the obliga-
tion of any Federal agency to disclose under section 552 of 
title 5, United States Code, any information, including informa-
tion relating to— 
(A) listed agents and toxins, or individuals seeking 
access to such agents and toxins; 
(B) registered persons, or persons seeking to register 
their possession, use, or transfer of such agents and toxins; 
(C) general safeguard and security policies and require-
ments under regulations under subsections (b) and (c); 
or 
(D) summary or statistical information concerning reg-
istrations, registrants, denials or revocations of registra-
tions, listed agents and toxins, inspection evaluations and 
reports, or individuals seeking access to such agents and 
toxins. 
(5) DISCLOSURES TO CONGRESS; OTHER DISCLOSURES.—This 
subsection may not be construed as providing any authority— 
(A) to withhold information from the Congress or any 
committee or subcommittee thereof; or 
(B) to withhold information from any person under 
any other Federal law or treaty. 
(i) CIVIL MONEY PENALTY.— 
,: 
116 STAT. 656 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
Deadlines. 
Rules. 
7 u s e 8401 note. 
(1) IN GENERAL.—In addition to any other penalties that 
may apply under law, any person who violates any provision 
of regulations under subsection (b) or (c) shall be subject to 
the United States for a civil money penalty in an amount 
not exceeding $250,000 in the case of an individual and 
$500,000 in the case of any other person. 
(2) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions 
of sections 423 and 425(2) of the Plant Protection Act (7 U.S.C. 
7733 and 7735(2)) shall apply to a civil money penalty or 
activity under paragraph (1) in the same msinner as such 
provisions apply to a penalty or activity under the Plant Protec-
tion Act. 
0') NOTIFICATION IN EVENT OF RELEASE.—^Regulations under 
subsections (b) and (c) shall require the prompt notification of 
the Secretary by a registered person whenever a release, meeting 
criteria established by the Secretary, of a listed agent or toxin 
has occurred outside of the biocontainment area of a facility of 
the registered person. Upon receipt of such notification and a finding 
by the Secretary that the release poses a threat to animal or 
plant health, or animal or plant products, the Secretary shall take 
appropriate action to notify relevant Federal, State, and local 
authorities, and, if necessary, other appropriate persons (including 
the public). If the released listed agent or toxin is an overlap 
agent or toxin, the Secretary shall promptly notify the Secretary 
of Health and Human Services upon notification by the registered 
person. 
(k) REPORTS.—The Secretary shall report to the Congress 
annually on the number and nature of notifications received under 
subsection (e)(8) (relating to theft or loss) and subsection (j) (relating 
to releases). 
(1) DEFINITIONS.—^For purposes of this section: 
(1) The terms "biological agent" and "toxin" have the 
meanings given such terms in section 178 of title 18, United 
States Code. 
(2) The term "listed agents and toxins" means biological 
agents and toxins listed pursuant to subsection (a)(1). 
(3) The term "listed agents or toxins" means biological 
agents or toxins listed pursuant to subsection (a)(1). 
(4) The terms "overlap agents and toxins" and "overlap 
agent or toxin" have the meaning given such terms in sub-
section (g)(lXA)(ii). 
(5) TTie term "person" includes Federal, State, and local 
governmental entities. 
(6) The term "registered person" means a person registered 
under regulations under subsection (b) or (c). 
(7) The term "Secretary" means the Secretary of Agri-
culture. 
(m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
such sums as may be necessary for each of the fiscal years 2002 
through 2007, in addition to other funds that may be available. 
SEC. 213. IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE. 
(a) DATE CERTAIN FOR PROMULGATION OF LIST.—^Not later than 
60 days after the date of the enactment of this Act, the Secretary 
of Agriculture (referred to in this section as the "Secretary") shall 
promulgate an interim final rule that establishes the initial list 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 657 
under section 212(a)(1), In promulgating such rule, the Secretary 
shall provide written guidance on the manner in which the notice 
required in subsection (b) is to be provided to the Secretary. 
(b) DATE CERTAIN FOR NOTICE OF POSSESSION.—Not later than 
60 days after the date on which the Secretary promulgates the 
interim final rule under subsection (a), all persons (unless exempt 
under section 212(g)) in possession of biological agents or toxins 
included on the list referred to in subsection (a) shall notify the 
Secretary of such possession. 
(c) 
DATE 
CERTAIN 
FOR PROMULGATION; 
EFFECTIVE 
DATE 
REGARDING CRIMINAL AND CIVIL PENALTIES.—Not later than 180 
days after the date of the enactment of this Act, the Secretary 
shall promulgate an interim final rule for carrying out section 
212, other than for the list referred to in subsection (a) of this 
section (but such rule may incorporate by reference provisions 
promulgated pursuant to subsection (a)). Such interim final rule 
shall take effect 60 days after the date on which such rule is 
promulgated, including for purposes of— 
(1) section 175b(c) of title 18, United States Code (relating 
to criminal penalties), as added by section 231(a)(5) of this 
Act; and 
(2) section 212(i) of this Act (relating to civil penalties). 
(d) TRANSITIONAL PROVISION REGARDING CURRENT RESEARCH 
AND EDUCATION.—^The interim final rule under subsection (c) shall 
include time frames for the applicability of the rule that minimize 
disruption of research or educational projects that involve biological 
agents and toxins listed pursuant to section 212(a)(1) and that 
were underway as of the effective date of such rule. 
Guidelines. 
Rules. 
Subtitle C—Interagency Coordination 
Regarding Overlap Agents and Toxins 
SEC. 221. INTERAGENCY COORDINATION. 
j 
(a) IN GENERAL.— 
(1) COORDINATION.—^The Secretary of Agriculture and the 
Secretary of Health and Human Services shall in accordance 
with this section coordinate activities regarding overlap agents 
and toxins. 
(2) OVERLAP AGENTS AND TOXINS; OTHER TERMS.—^For pur-
poses of this section: 
(A) The term "overlap agent or toxin" means a 
biological agent or toxin thatr— 
(i) is listed pursuant to section 315A(a)(l) of the 
Public Health Service Act, as added by section 201 
ofthis Act; and 
(ii) is listed pursuant to section 212(a)(1) of this 
Act. 
(B) The term "section 35lA program" means the pro-
gram under section 35 lA of the Public Health Service 
Act. 
(C) The term "section 212 program" means the program 
under section 212 ofthis Act. 
(b) CERTAIN MATTERS.—In canying out the section 35lA pro-
gram and the section 212 program, the Secretary of Health and 
Human Services and the Secretary of Agriculture shall, to the 
7 use 8411. 
116 STAT. 658 
PUBLIC LAW 107-188-^UNE 12, 2002 
greatest extent practicable, coordinate activities to achieve the fol-
lowing purposes: 
(1) To minimize any conflicts between the regulations 
issued under, and activities carried out under, such programs. 
(2) To minimize the administrative burden on persons sub-
ject to regulation under both of such programs. 
(3) To ensure the appropriate availability of biological 
agents and toxins for legitimate biomedical, agricultural or 
veterinary research, education, or other such purposes. 
(4) To ensure that registration information for overlap 
agents and toxins under the section 35 lA and section 212 
programs is contained in both the national database under 
the section 35 lA program and the national database under 
the section 212 program. 
(c) MEMORANDUM OF UNDERSTANDING.— 
(1) IN GENERAL.—^Promptly after the date of the enactment 
of this Act, the Secretary of Agriculture and the Secretary 
of Health and Human Services shall enter into a memorandum 
of imderstanding regarding overlap agents and toxins that is 
in accordance with paragraphs (2) through (4) and contains 
such additional provisions as the Secretary of Agriculture and 
the Secretary of Health and Human Services determine to 
be appropriate. 
(2) SINGLE REGISTRATION SYSTEM REGARDING REGISTERED 
PERSONS.—^The memorandum of understanding under para-
graph (1) shall provide for the development and implementation 
of a single system of registration for persons who possess, 
use, or transfer overlap agents or toxins and are required 
to register under both the section 351A program and the section 
212 program. For purposes of such system, the memorandum 
shall provide for the development and implementation of the 
following: 
(A) A single registration form through which the person 
submitting the form provides all information that is 
required for registration under the section 35 lA program 
and all information that is required for registration under 
the section 212 program. 
(B) A procedure through which a person may choose 
to submit the single registration form to the agency admin-
istering the section 35 lA program (in the manner provided 
under such program), or to the agency administering the 
section 212 program (in the manner provided under such 
program). 
(C) A procedure through which a copy of a single 
registration form received pursuant to subparagraph (B) 
by the agency administering one of such programs is 
promptly provided to the agency administering the other 
program. 
(D) A procedure through which the agency receiving 
the single registration form under one of such programs 
obtains the concurrence of the agency administering the 
other program that the requirements for registration under 
the other program have been met. 
(E) A procedure through which— 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
116 STAT. 659 
(i) the agency receiving the single registration form 
under one of such programs informs the agency admin-
istering the other program whether the receiving 
agency has denied the registration; and 
(ii) each of such agencies ensures that registrations 
are entered into the national database of registered 
persons that is maintained by each such agency. 
(3) 
PROCESS OF IDENTIFICATION.—^With respect to 
the 
process of identification under the section 35 lA program and 
the section 212 program for names and other identif5dng 
information submitted to the Attorney General (relating to 
certain categories of individuals and entities), the memorandum 
of understanding under paragraph (1) shall provide for the 
development and implementation of the following: 
(A) A procedure through which a person who is 
required to submit information pursuant to such process 
makes (in addition to the submission to the Attorney Gen-
eral) a submission, at the option of the person, to either 
the agency administering the section 35 lA program or 
the agency administering the section 212 program, but 
not both, which submission satisfies the requirement of 
submission for both of such programs. 
(B) A procedure for the sharing by both of such agencies 
of information received from the Attorney General by one 
of such agencies pursuant to the submission under subpara-
graph (A). 
(C) A procedure through which the agencies admin-
istering such programs concur in determinations that 
access to overlap agents and toxins will be granted. 
(4) COORDINATION OF INSPECTIONS AND ENFORCEMENT.— 
The memorandum of understanding under paragraph (1) shall 
provide for the development and implementation of procedures 
under which Federal personnel under the section 35 lA program 
and the section 212 program may share responsibilities for 
inspections and enforcement activities under such programs 
regarding overlap agents and toxins. Activities carried out 
under such procedures by one of such programs on behalf 
of the other may be carried out with or without reimbursement 
by the agency that administers the other program. 
(5) 
DATE 
CERTAIN 
FOR 
IMPLEMENTATION.—The memo- DeadUne. 
randum of understanding under paragraph (1) shall be imple-
mented not later than 180 days after the date of the enactment 
of this Act. Until the single system of registration under para-
graph (2) is implemented, persons who possess, use, or transfer 
overlap agents or toxins shall register under both the section 
35 lA program and the section 212 program. 
(d) JOINT REGULATIONS.—Not later than 18 months after the Deadline. 
date on which the single system of registration under subsection 
(c)(2) is implemented, the Secretary of Health and Human Services 
and the Secretary of Agriculture shall jointly issue regulations 
for the possession, use, and transfer of overlap agents and toxins 
that meet the requirements of both the section 351A program 
and the section 212 program. 
116 STAT. 660 
PUBLIC LAW 107-188—JUNE 12, 2002 
Subtitle D—Criminal Penalties Regarding 
Certain Biological Agents and Toxins 
SEC. 231. CRIMINAL PENALTIES. 
(a) IN GENERAL.—Section 175b of title 18, United States Code, 
as added by section 817 of Public Law 107-56, is amended— 
(1) by striking "(a)" and inserting "(a)(1)"; 
(2) by transferring subsection (c) from the current place-
ment of the subsection and inserting the subsection before 
subsection (b); 
(3) by striking "(c)" and inserting "(2); 
(4) by redesignating subsection (b) as subsection (d); and 
(5) by inserting before subsection (d) (as so redesignated) 
the following subsections: 
"(b) TRANSFER TO UNREGISTERED PERSON.— 
"(1) SELECT AGENTS.—^Whoever transfers a select agent 
to a person who the transferor knows or has reasonable cause 
to believe is not registered as required by regulations under 
subsection (b) or (c) of section 35 lA of the Public Health Service 
Act shall be fined under this title, or imprisoned for not more 
than 5 years, or both. 
"(2) CERTAIN OTHER BIOLOGICAL AGENTS AND TOXINS.—Who-
ever transfers a biological agent or toxin listed pursuant to 
section 212(a)(1) of the Agricultural Bioterrorism Protection 
Act of 2002 to a person who the transferor knows or has 
reasonable cause to believe is not registered as required by 
regulations under subsection (b) or (c) of section 212 of such 
Act shall be fined under this title, or imprisoned for not more 
than 5 years, or both. 
"(c) UNREGISTERED FOR POSSESSION.— 
"(1) SELECT AGENTS.—^Whoever knowingly possesses a 
biological agent or toxin where such agent or toxin is a select 
agent for which such person has not obtained a registration 
required by regulations under section 351A(c) of the Public 
Health Service Act shall be fined under this title, or imprisoned 
for not more than 5 years, or both. 
"(2) CERTAIN OTHER BIOLOGICAL AGENTS AND TOXINS.—^Who-
ever knowingly possesses a biological agent or toxin where 
such agent or toxin is a biological agent or toxin listed pursuant 
to section 212(a)(1) of the Agricultural Bioterrorism Protection 
Act of 2002 for which such person has not obtained a registra-
tion required by regulations under section 212(c) of such Act 
shall be fined under this title, or imprisoned for not more 
than 5 years, or both.". 
(b) CONFORMING AMENDMENTS.—Chapter 10 of title 18, United 
States Code, is amended— 
(1) in section 175b (as added by section 817 of Public 
Law 107-56 and amended by subsection (a) of this section)— 
(A) in subsection (d)(1), by striking "The term" and 
all that follows through "does not include" and inserting 
the following: "The term 'select agent' means a biological 
agent or toxin to which subsection (a) applies. Such term 
(including for purposes of subsection (a)) does not include"; 
and 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 661 
(B) in the heading for the section, by striking "Posses-
sion by restricted persons" and inserting "Select 
agents; certain other agents"; and 
(2) in the chapter analysis, in the item relating to section 
175b, by striking "Possession by restricted persons." and 
inserting "Select agents; certain other agents.". 
(c) TECHNICAL CORRECTIONS.—Chapter 10 of title 18, United 
States Code, as amended by section 817 of Public Law 107-56 
and subsections (a) and (b) of this section, is amended— 
(1) in section 175(c), by striking "protective" and all that 
follows and inserting "protective, bona fide research, or other 
peaceful purposes."; 
(2) in section 175b— 
I 
(A) in subsection (a)(1), by striking "described in sub-
section (b)" and all that follows and inserting the following: 
"shall ship or transport in or affecting interstate or foreign 
commerce, or possess in or affecting interstate or foreign 
commerce, any biological agent or toxin, or receive any 
biological agent or toxin that has been shipped or trans-
ported in interstate or foreign commerce, if the biological 
agent or toxin is listed as a select agent in Appendix 
A of part 72 of title 42, Code of Federal Regulations, 
pursuant to section 35lA of the Public Health Service 
Act, and is not exempted under subsection (h) of section 
72.6, or Appendix A of part 72, of title 42, Code of Federal 
Regulations."; and 
(B) in subsection (d)(3), by striking "section 1010(a)(3)" 
and inserting "section 101(a)(3)"; 
(3) in section 176(a)(1)(A), by striking "exists by reason 
of and inserting "pertains to"; and 
(4) in section 178— 
(A) in paragraph (1), by striking "means any micro-
organism" and all that follows through "product, capable 
of and inserting the following: "means any microorganism 
(including, but not limited to, bacteria, viruses, fungi, 
rickettsiae or protozoa), or infectious substance, or any 
naturally occurring, bioengineered or S3nithesized compo-
nent of any such microorganism or infectious substance, 
capable of; 
(B) in paragraph (2), by striking "means the toxic" 
and all that follows through "including—" and inserting 
the following: "means the toxic material or product of 
plants, animals, microorganisms (including, but not limited 
to, bacteria, viruses, fungi, rickettsiae or protozoa), or infec-
tious substances, or a recombinant or synthesized molecule, 
whatever their origin and method of production, and 
includes—"; and 
(C) in paragraph (4), by striking "recombinant mol-
ecule," and all that follows through "biotechnology," and 
inserting "recombinant or synthesized molecule,". 
(d) ADDITIONAL TECHNICAL CORRECTION.—Section 2332a of title 
18, United States Code, is amended— 
(1) in subsection (a), in the matter preceding paragraph 
(1), by striking "section 229F)" and all that follows through 
"section 178)—" and inserting "section 229F)—"; and 
, 
116 STAT. 662 
PUBLIC LAW 107-188—JUNE 12, 2002 
(2) in subsection (c)(2)(C), by striking "a disease organism" 
and inserting "a biological agent, toxin, or vector (as those 
terms are defined in section 178 of this title)". 
TITLE III—PROTECTING SAFETY AND 
SECURITY OF FOOD AND DRUG SUPPLY 
Subtitle A—Protection of Food Supply 
21 use 341 note. 
SEC. 301. FOOD SAFETY AND SECURITY STRATEGY. 
(a) IN GENERAL.—^The President's Council on Food Safety (as 
established by Executive Order No. 13100) shall, in consultation 
with the Secretary of Transportation, the Secretary of the Treasury, 
other relevant Federal agencies, the food industry, consumer and 
producer groups, scientific organizations, and the States, develop 
a crisis communications and education strategy with respect to 
bioterrorist threats to the food supply. Such strategy shall address 
threat assessments; technologies and procedures for securing food 
processing and manufacturing facilities and modes of transpor-
tation; response and notification procedures; and risk communica-
tions to the public. 
(b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
implementing the strategy developed under subsection (a), there 
are authorized to be appropriated $750,000 for fiscal year 2002, 
and such sums as may be necessary for each subsequent fiscal 
year. 
SEC. 302. P R O T E C T I O N AGAINST ADULTERATION OF FOOD. 
(a) INCREASING INSPECTIONS FOR DETECTION OF ADULTERATION 
OF FOOD.—Section 801 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 381) is amended by adding at the end the following 
subsection: 
"(h)(1) The Secretary shall give high priority to increasing 
the number of inspections under this section for the purpose of 
enabling the Secretary to inspect food offered for import at ports 
of entry into the United States, with the greatest priority given 
to inspections to detect the intentional adulteration of food.". 
(b) IMPROVEMENTS TO INFORMATION MANAGEMENT SYSTEMS.— 
Section 801(h) of the Federal Food, Drug, and Cosmetic Act, as 
added by subsection (a) of this section, is amended by adding 
at the end the following paragraph: 
"(2) The Secretary shall give high priority to making necessary 
improvements to the information management systems of the Food 
and Drug Administration that contain information related to foods 
imported or offered for import into the United States for purposes 
of improving the ability of the Secretary to allocate resources, 
detect the intentional adulteration of food, and facilitate the 
importation of food that is in compliance with this Act.". 
(c) LINKAGES WITH APPROPRIATE PUBLIC ENTITIES.—Section 
801(h) of the Federal Food, Drug, and Cosmetic Act, as amended 
by subsection (b) of this section, is amended by adding at the 
end the following paragraph: 
"(3) The Secretary shall improve linkages with other regulatory 
agencies of the Federal Government that share responsibility for 
food safety, and shall with respect to such safety improve linkages 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 663 
with the States and Indian tribes (as defined in section 4(e) of 
the Indian Self-Determination and Education Assistance Act (25 
U.S.C. 450b(e))).". 
(d) TESTING FOR RAPID 
DETECTION OF ADULTERATION OF 
FOOD.—Section 801 of the Federal Food, Drug, and Cosmetic Act, 
as amended by subsection (a) of this section, is amended by adding 
at the end the following: 
"(i)(l) For use in inspections of food under this section, the 
Secretary shall provide for research on the development of tests 
and sampling methodologies— 
"(A) whose purpose is to test food in order to rapidly 
detect the adulteration of the food, with the greatest priority 
given to detect the intentional adulteration of food; and 
"(B) whose results offer significant improvements over the 
available technology in terms of accuracy, timing, or costs. 
"(2) In providing for research under paragraph (1), the Secretary 
shall give priority to conducting research on the development of 
tests that are suitable for inspections of food at ports of entry 
into the United States. 
"(3) In providing for research under paragraph (1), the Secretary 
shall as appropriate coordinate with the Director of the Centers 
for Disease Control and Prevention, the Director of the National 
Institutes of Health, the Administrator of the Environmental Protec-
tion Agency, and the Secretary of Agriculture. 
"(4) The Secretary shall annually submit to the Committee Reports. 
on Energy and Commerce of the House of Representatives, and 
the Committee on Health, Education, Labor, and Pensions of the 
Senate, a report describing the progress made in research under 
paragraph (1), including progress regarding paragraph (2).". 
(e) ASSESSMENT OF THREAT OF INTENTIONAL ADULTERATION Deadline. 
OF FOOD.—The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall ensure that, 
not later than six months after the date of the enactment of this 
Act— 
(1) the assessment that (as of such date of enactment) 
is being conducted on the threat of the intentional adulteration 
of food is completed; and 
(2) a report describing the findings of the assessment is Reports, 
submitted to the Committee on Energy and Commerce of the 
House of Representatives and to the Committee on Health, 
Education, Labor, and Pensions of the Senate. 
(f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section and the amendments made by this section, 
there are authorized to be appropriated $100,000,000 for fiscal 
year 2002, and such sums as may be necessary for each of the 
fiscal years 2003 through 2006, in addition to other authorizations 
of appropriations that are available for such purpose. 
SEC. 303. ADMINISTRATIVE DETENTION. 
(a) EXPANDED AUTHORITY.—Section 304 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding 
at the end the following subsection: 
, 
"(h) ADMINISTRATIVE DETENTION OF FOODS.— 
i 
"(1) DETENTION AUTHORITY.— 
"(A) IN GENERAL.—^An officer or qualified employee of 
the Food and Drug Administration may order the detention, 
in accordance with this subsection, of any article of food 
116 STAT. 664 
PUBLIC LAW 107-188—JUNE 12, 2002 
that is found during an inspection, examination, or inves-
tigation under this Act conducted by such officer or quali-
fied employee, if the officer or qualified employee has cred-
ible evidence or information indicating that such article 
presents a threat of serious adverse health consequences 
or death to humans or animals. 
"(B) SECRETARY'S APPROVAL.—An article of food may 
be ordered detained under subparagraph (A) only if the 
Secretary or an official designated by the Secretary 
approves the order. An official may not be so designated 
unless the official is the director of the district under 
this Act in which the article involved is located, or is 
an official senior to such director. 
"(2) PERIOD OF DETENTION.—An article of food may be 
detained under paragraph (1) for a reasonable period, not to 
exceed 20 days, unless a greater period, not to exceed 30 
days, is necessary, to enable the Secretary to institute an 
Regulation. 
action under subsection (a) or section 302. The Secretary shall 
by regulation provide for procedures for instituting such action 
on an expedited basis with respect to perishable foods. 
"(3) SECURITY OF DETAINED ARTICLE.—^An order under para-
graph (1) with respect to an article of food may require that 
such article be labeled or marked as detained, and shall require 
that the article be removed to a secure facility, as appropriate. 
An article subject to such an order shall not be transferred 
by any person from the place at which the article is ordered 
detained, or from the place to which the article is so removed, 
as the case may be, until released by the Secretary or until 
the expiration of the detention period applicable under such 
order, whichever occurs first. This subsection may not be con-
strued as authorizing the delivery of the article pursuant to 
the execution of a bond while the article is subject to the 
order, and section 801(b) does not authorize the delivery of 
the article pursuant to the execution of a bond while the article 
is subject to the order. 
"(4) APPEAL OF DETENTION ORDER.— 
"(A) IN GENERAL.—^With respect to an article of food 
ordered detained under paragraph (1), any person who 
would be entitled to be a claimant for such article if the 
article were seized under subsection (a) may appeal the 
order to the Secretary. Within five days after such an 
appeal is filed, the Secretary, after providing opportunity 
for an informal hearing, shall confirm or terminate the 
order involved, and such confirmation by the Secretary 
shall be considered a final agency action for purposes of 
section 702 of title 5, United States Code. If during such 
five-day period the Secretary fails to provide such an oppor-
tunity, or to confirm or terminate such order, the order 
is deemed to be terminated. 
"(B) 
EFFECT 
OF INSTITUTING 
COURT ACTION.—The 
process under subparagraph (A) for the appeal of an order 
under paragraph (1) terminates if the Secretary institutes 
an action under subsection (a) or section 302 regarding 
the article of food involved.". 
(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: 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 665 
"(bb) The transfer of an article of food in violation of an order 
under section 304(h), or the removal or alteration of any mark 
or label required by the order to identify the article as detained.". 
(c) TEMPORARY HOLDS AT PORTS OF ENTRY.—Section 801 of 
the Federal Food, Drug, and Cosmetic Act, as amended by section 
302(d)of this Act, is amended by adding at the end the following: 
21USC 381. 
"(j)(l) If an officer or qualified employee of the Food and Drug 
Administration has credible evidence or information indicating that 
an Eirticle of food presents a threat of serious adverse health con-
sequences or death to humans or animals, and such officer or 
qualified employee is unable to inspect, examine, or investigate 
such article upon the article being offered for import at a port 
of entry into the United States, the officer or qu£ilified employee 
shall request the Secretary of Treasury to hold the food at the 
port of entry for a reasonable period of time, not to exceed 24 
hours, for the purpose of enabling the Secretary to inspect, examine, 
or investigate the article as appropriate. 
"(2) The Secretary shall request the Secretary of Treasury 
to remove an article held pursuant to paragraph (1) to a secure 
facility, as appropriate. During the period of time that such article 
is so held, the article shall not be transferred by any person from 
the port of entry into the United States for the article, or from 
the secure facility to which the eirticle has been removed, as the 
case may be. Subsection (b) does not authorize the delivery of 
the article pursuant to the execution of a bond while the article 
is so held. 
"(3) An officer or qualified employee of the Food and Drug 
Administration may make a request under paragraph (1) only if 
the Secretary or an official designated by the Secretary approves 
the request. An official may not be so designated unless the official 
is the director of the district luider this Act in which the article 
involved is located, or is an official senior to such director. 
"(4) With respect to £in article of food for which a request 
under paragraph (1) is made, the Secretary, promptly after the 
request is made, shall notify the State in which the port of entry 
involved is located that the request has been made, and as 
applicable, that such article is being held under this subsection.". 
SEC. 304. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT 
VIOLATIONS. 
„ (a) DEBARMENT AUTHORITY.— 
(1) PERMISSIVE DEBARMENT.—Section 306(b)(1) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(l)) is 
amended— 
(A) in subparagraph (A), by striking "or" after the 
comma at the end; 
(B) in subparagraph (B), by striking the period at 
the end and inserting ", or"; and 
(C) by adding at the end the following subparagraph: 
"(C) a person from importing an article of food or 
offering such an article for import into the United States.". 
(2) AMENDMENT REGARDING DEBARMENT GROUNDS.—Section 
306(b)) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
335a(b)) is amended— 
(A) in paragraph (2), in the matter preceding subpara-
graph (A), by inserting "subparagraph (A) or (B) of before 
"paragraph (1)"; 
116 STAT. 666 
PUBLIC LAW 107-188-^UNE 12, 2002 
(B) by redesignating paragraph (3) as paragraph (4); 
and 
(C) by inserting after paragraph (2) the following para-
graph: 
"(3) PERSONS SUBJECT TO PERMISSIVE DEBARMENT; FOOD 
IMPORTATION.—^A person is subject to debarment under para-
graph (1)(C) if— 
"(A) the person has been convicted of a felony for 
conduct relating to the importation into the United States 
of any food; or 
"(B) the person has engaged in a pattern of importing 
or offering for import adulterated food that presents a 
threat of serious adverse health consequences or death 
to humans or animals.". 
(b) CONFORMING AMENDMENTS.—Section 306 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is amended— 
(1) in subsection (a), in the heading for the subsection, 
by 
striking 
"MANDATORY 
DEBARMENT.—" 
and 
inserting 
"MANDATORY DEBARMENT; CERTAIN DRUG APPLICATIONS.—"; 
(2) in subsection (b)— 
(A) in the heading for the subsection, by striking 
"PERMISSIVE DEBARMENT.—" and inserting "PERMISSIVE 
DEBARMENT; 
CERTAIN 
DRUG 
APPLICATIONS; 
FOOD 
IMPORTS.—"; and 
(B) in paragraph (2), in the heading for the paragraph, 
by striking "PERMISSIVE DEBARMENT.—" and inserting 
"PERMISSIVE DEBARMENT; CERTAIN DRUG APPLICATIONS.— 
(3) in subsection (c)(2)(A)(iii), by striking "subsection (b)(2)" 
and inserting "paragraph (2) or (3) of subsection (b)"; 
(4) in subsection (d)(3)— 
(A) in subparagraph (A)(i), by striking "or (b)(2)(A)" 
and inserting " or paragraph (2)(A) or (3) of subsection 
(b)"; 
(B) in subparagraph 
(A)(ii)(II), by inserting "in 
applicable cases," before "sufficient audits"; 
(C) in subparagraph (B), in each of clauses (i) and 
(ii), by inserting "or subsection (b)(3)" after "subsection 
(b)(2)(B)"; and 
(D) in subparagraph (B)(ii), by inserting before the 
period the following: "or the food importation process, as 
the case may be". 
(c) EFFECTIVE DATES.—Section 306(1)(2) of the Federal Food, 
21 use 335a. 
Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) is amended— 
(1) in the first sentence— 
(A) by striking "and" after "subsection (b)(2),"; and 
(B) by inserting ", and subsection (b)(3)(A)" after "sub-
section (b)(2)(B)"; and 
(2) in the second sentence, by inserting ", subsection 
(b)(3)(B)," after "subsection (b)(2)(B)". 
(d) PROHIBITED ACT.—Section 301 of the Federal Food, Drug, 
and Cosmetic Act, as amended by section 303(b) of this Act, is 
amended by adding at the end the following: 
"(cc) The importing or offering for import into the United States 
of an article of food by, with the assistance of, or at the direction 
of, a person debarred under section 306(b)(3).". 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 667 
(e) IMPORTATION BY DEBARRED PERSONS.—Section 801 of the 
Federal Food, Drug, and Cosmetic Act, as amended by section 
303(c) of this Act, is amended by adding at the end the following 21USC 381. 
subsection: 
"(k)(l) If an article of food is being imported or offered for 
import into the United States, and the importer, owner, or consignee 
of the article is a person who has been debarred under section 
306(b)(3), such article shall be held at the port of entry for the 
article, and may not be delivered to such person. Subsection (b) 
does not authorize the delivery of the article pursuant to the execu-
tion of a bond while the article is so held. The article shall be 
removed to a secure facility, as appropriate. During the period 
of time that such article is so held, the article shall not be trans-
ferred by any person from the port of entry into the United States 
for the article, or from the secure facility to which the article 
has been removed, as the case may be. 
"(2) An article of food held under paragraph (1) may be delivered 
to a person who is not a debarred person under section 306(b)(3) 
if such person affirmatively establishes, at the expense of the per-
son, that the article complies with the requirements of this Act, 
as determined by the Secretary.". 
SEC. 305. REGISTRATION OF FOOD FACILITIES. 
(a) IN GENERAL.—Chapter IV of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at 
the end the following: 
i 
"SEC. 415. REGISTRATION OF FOOD FACILITIES. 
I 
21 USC 350d. 
"(a) REGISTRATION.— 
"(1) IN GENERAL.—The Secretary shall by regulation require Regulations. 
that any facility engaged in manufacturing, processing, packing, 
or holding food for consumption in the United States be reg-
istered with the Secretary. To be registered— 
"(A) for a domestic facility, the owner, operator, or 
agent in charge of the facility shall submit a registration 
to the Secretary; and 
"(B) for a foreign facility, the owner, operator, or agent 
in charge of the facility shall submit a registration to 
the Secretary and shall include 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 registration under paragraph 
(1) to the Secretary containing 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 Sec-
retary through guidance, the general food category (as identified 
under section 170.3 of title 21, Code of Federal Regulations) 
of £iny food manufactured, processed, packed, or held at such 
facility. The registrant shall notify the Secretary in a timely 
Notification. 
manner of changes to such information. 
"(3) PROCEDURE.—Upon receipt of a completed registration 
Notification. 
described in paragraph (1), the Secretary shall notify the reg-
istrant of the receipt of such registration and assign a registra-
tion number to each registered facility. 
"(4) LIST.—The Secretary shall compile and maintain an Records. 
up-to-date list of facilities that are registered under this section. 
Such list and any registration docimaents submitted pursuant 
116 STAT. 668 
PUBLIC LAW 107-188—JUNE 12, 2002 
to this subsection shall not be subject to disclosure under sec-
tion 552 of title 5, United States Code. Information derived 
from such list or registration docimients shall not be subject 
to disclosm-e under section 552 of title 5, United States Code, 
to the extent that it discloses the identity or location of a 
specific registered person. 
"(b) FACILITY.—For purposes of this section: 
"(1) The term 'facility' includes any factory, warehouse, 
or establishment (including a factory, warehouse, or establish-
ment of an importer) that manufactures, processes, packs, or 
holds food. Such term does not include farms; restaurants; 
other retail food establishments; nonprofit food establishments 
in which food is prepared for or served directly to the consumer; 
or fishing vessels (except such vessels engaged in processing 
as defined in section 123.3(k) of title 21, Code of Federal Regula-
tions). 
"(2) The term 'domestic facility' means a facility located 
in any of the States or Territories. 
''(3)(A) The term 'foreign facility' mesuis a facility that 
manufacturers, processes, packs, or holds food, but only if food 
from such facility is exported to the United States without 
further processing or packaging outside the United States. 
"(B) A food may not be considered to have undergone 
further processing or packaging for purposes of subparagraph 
(A) solely on the basis that labeling was added or that any 
similar activity of a de minimis nature was carried out with 
respect to the food. 
"(c) RULE OF CONSTRUCTION.—Nothing in this section shall 
be construed to authorize the Secreteiry to require an application, 
review, or licensing process.". 
(b) PROfflBiTED ACTS.—Section 301 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 331), as amended by section 304(d) 
of this Act, is amended by adding at the end the following: 
"(dd) The failure to register in accordance with section 415.". 
(c) IMPORTATION; FAILURE TO REGISTER.—Section 801 of the 
Federal Food, Drug, and Cosmetic Act, as simended by section 
21 use 381. 
304(e) of this Act, is eimended by adding at the end the following 
subsection: 
"(1X1) If an Eirticle of food is being imported or offered for 
import into the United States, and such article is from a foreign 
facility for which a registration has not been submitted to the 
Secretary under section 415, such article shall be held at the 
port of entry for the Euticle, and may not be delivered to the 
importer, owner, or consignee of the article, until the foreign facility 
is so registered. Subsection (b) does not authorize the delivery 
of the article pursuemit to the execution of a bond while the article 
is so held. The article shall be removed to a secure facility, as 
appropriate. During the period of time that such article is so held, 
the article sheill not be transferred by any person from the port 
of entry into the United States for the article, or from the secure 
facility to which the article has been removed, as the case may 
be.". 
21 use 350d 
(d) ELECTRONIC FILING.—For the purpose of reducing paper-
"o*«- 
work and reporting burdens, the Secretary of Health and Human 
Services may provide for, and encourage the use of, electronic 
methods of submitting to the Secretary registrations required pursu-
ant to this section. In providing for the electronic submission of 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 669 
such registrations, the Secretary shall ensure adequate authentica-
tion protocols are used to enable identification of the registrant 
and validation of the data as appropriate. 
(e) RULEMAKING; EFFECTIVE DATE.—Not later than 18 months DeadUne. 
after the date of the enactment of this Act, the Secretary of Health 
and Human Services shall promulgate proposed and final regula-
tions for the requirement of registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act (as added by subsection 
(a) of this section). Such requirement of registration takes effect— 
(1) upon the effective date of such final regulations; or 
(2) upon the expiration of such 18-month period if the 
final regulations have not been made effective as of the expira-
tion of such period, subject to compliance with the final regula-
tions when the final regulations are made effective. 
SEC. 306. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS. 
(a) IN GENERAL.—Chapter IV of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 305 of this Act, is amended 
by inserting before section 415 the following section: 
"SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS. 
21USC 350c. 
"(a) RECORDS INSPECTION.—If the Secretary has a reasonable 
belief that an article of food is adulterated and presents a threat 
of serious adverse health consequences or death to humans or 
animals, each person (excluding farms and restaurants) who manu-
factures, processes, packs, distributes, receives, holds, or imports 
such article shall, at the request of an officer or employee duly 
designated by the Secretary, permit such officer or employee, upon 
presentation of appropriate credentials and a written notice to 
such person, at reasonable times and within reasonable limits and 
in a reasonable manner, to have access to and copy all records 
relating to such article that are needed to assist the Secretary 
in determining whether the food is adulterated and presents a 
threat of serious adverse health consequences or death to humans 
or animals. The requirement under the preceding sentence applies Applicability, 
to all records relating to the manufacture, processing, packing, 
distribution, receipt, holding, or importation of such article main-
tained by or on behalf of such person in any format (including 
paper and electronic formats) and at any location. 
"(b) REGULATIONS CONCERNING RECORDKEEPING.—^The Sec-
retary, in consultation and coordination, as appropriate, with other 
Federal departments and agencies with responsibilities for regu-
lating food safety, may by regulation establish requirements 
regarding the establishment and maintenance, for not longer than 
two years, of records by persons (excluding farms and restaurants) 
who manufacture, process, pack, transport, distribute, receive, hold, 
or import food, which records are needed by the Secretary for 
inspection to allow the Secretary to identify the immediate previous 
sources and the immediate subsequent recipients of food, including 
its packaging, in order to address credible threats of serious adverse 
health consequences or death to humans or animals. The Secretary 
shall take into account the size of a business in promulgating 
regulations under this section. 
"(c) PROTECTION OF SENSITIVE INFORMATION.—The Secretary 
shall take appropriate measures to ensure that there are in effect 
effective procedures to prevent the unauthorized disclosure of any 
trade secret or confidential information that is obtained by the 
Secretary pursuant to this section. 
116 STAT. 670 
PUBLIC LAW 107-188—JUNE 12, 2002 
Deadline. 
21 u s e 350c 
note. 
Regulations. 
"(d) LIMITATIONS.—This section shall not be construed— 
"(1) to limit the authority of the Secretary to inspect records 
or to require establishment and maintenance of records under 
any other provision of this Act; 
"(2) to authorize the Secretary to impose any requirements 
with respect to a food to the extent that it is within the 
exclusive jurisdiction of the 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.); 
"(3) to have any legal effect on section 552 of title 5, 
United States Code, or section 1905 of title 18, United States 
Code; or 
"(4) to extend to recipes for food, financial data, pricing 
data, personnel data, research data, or sales data (other than 
shipment data regarding sales).". 
(b) FACTORY INSPECTION.—Section 704(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended— 
(1) in paragraph (1), by inserting after the first sentence 
the following new sentence: "In the case of any person 
(excluding farms and restaurants) who manufactures, proc-
esses, packs, transports, distributes, holds, or imports foods, 
the inspection shall extend to all records and other information 
described in section 414 when the Secretary has a reasonable 
belief that an article of food is adulterated and presents a 
threat of serious adverse health consequences or death to 
humans or animals, subject to the limitations established in 
section 414(d)."; and 
(2) in paragraph (2), in the matter preceding subparagraph 
(A), by striking "second sentence" and inserting "third sen-
tence". 
(c) PROHIBITED ACT.—Section 301 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 331) is amended— 
(1) in paragraph (e)— 
(A) by striking "by section 412, 504, or 703" and 
inserting "by section 412, 414, 504, 703, or 704(a)"; and 
(B) by striking "under section 412" and inserting 
"under section 412, 414(b)"; and 
(2) in paragraph (j), by inserting "414," after "412,". 
(d) EXPEDITED RULEMAKING.—Not later than 18 months after 
the date of the enactment of this Act, the Secretary shall promulgate 
proposed and final regulations establishing recordkeeping require-
ments under subsection 414(b) of the Federal Food, Drug, and 
Cosmetic Act (as added by subsection (a)). 
SEC. 307. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS. 
(a) IN GENERAL.—Section 801 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 305(c) of this Act, is amended 
by adding at the end the following subsection: 
"(m)(l) In the case of an article of food that is being imported 
or offered for import into the United States, the Secretary, after 
consultation with the Secretary of the Treasury, shall by regulation 
require, for the purpose of enabling such article to be inspected 
at ports of entry into the United States, the submission to the 
Secretary of a notice providing the identity of each of the following: 
The article; the manufacturer and shipper of the article; if known 
within the specified period of time that notice is required to be 
PUBLIC LAW 107-188-JUNE 12, 2002 
116 STAT. 671 
provided, the grower of the article; the country from which the 
article originates; the country from which the article is shipped; 
and the anticipated port of entry for the article. An article of 
food imported or offered for import without submission of such 
notice in accordance with the requirements under this paragraph 
shall be refused admission into the United States. Nothing in this 
section may be construed as a limitation on the port of entry 
for an article of food. 
"(2)(A) Regulations under paragraph (1) shall require that a 
notice under such paragraph be provided by a specified period 
of time in advance of the time of the importation of the article 
of food involved or the offering of the food for import, which period 
shall be no less than the minimum amount of time necessary 
for the Secretary to receive, review, and appropriately respond 
to such notification, but may not exceed five days. In determining 
the specified period of time required under this subparagraph, 
the Secretary may consider, but is not limited to consideration 
of, the effect on commerce of such period of time, the locations 
of the various ports of entry into the United States, the various 
modes of transportation, the types of food imported into the United 
States, and any other such consideration. Nothing in the preceding 
sentence may be construed as a limitation on the obligation of 
the Secretary to receive, review, and appropriately respond to any 
notice under paragraph (1). 
"(B)(i) If an article of food is being imported or offered for 
import into the United States and a notice under paragraph (1) 
is not provided in advance in accordance with the requirements 
under paragraph (1), such article shall be held at the port of 
entry for the article, and may not be delivered to the importer, 
owner, or consignee of the article, until such notice is submitted 
to the Secretary, and the Secretary examines the notice and deter-
mines that the notice is in accordance with the requirements under 
paragraph (1). Subsection (b) does not authorize the delivery of 
the article pursuant to the execution of a bond while the article 
is so held. The article shall be removed to a secure facility, as 
appropriate. During the period of time that such article is so held, 
the article shall not be transferred by any person from the port 
of entry into the United States for the article, or from the secure 
facility to which the article has been removed, as the case may 
be. 
"(ii) In carrying out clause (i) with respect to an article of 
food, the Secretary shall determine whether there is in the posses-
sion of the Secretary any credible evidence or information indicating 
that such article presents a threat of serious adverse health con-
sequences or death to humans or animals. 
"(3)(A) This subsection may not be construed as limiting the 
authority of the Secretary to obtain information under any other 
provision of this Act. 
"(B) This subsection may not be construed as authorizing the 
Secretary to impose any requirements with respect to a food to 
the extent that it is within the exclusive jurisdiction of the Secretary 
of Agriculture pursuant to the Federal Meat Inspection Act (21 
US.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.).". 
116 STAT. 672 
PUBLIC LAW 107-188—JUNE 12, 2002 
(b) PROHIBITED ACT.—Section 301 of the Federal Food, Drug, 
21 use 331. 
and Cosmetic Act, as amended by section 305(b) of this Act, is 
amended by adding at the end the following: 
"(ee) llie importing or offering for import into the United States 
of an article of food in violation of the requirements under section 
801(m).". 
21 use 351 note. 
(c) RULEMAKING; EFFECTIVE DATE.— 
Deadline. 
(1) IN GENERAL.—Not later than 18 months after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall promulgate proposed and fingil regula-
tions for the requirement of providing notice in accordance 
with section 801(m) of the Federal Food, Drug, and Cosmetic 
Act (as added by subsection (a) of this section). Such require-
ment of notification takes effect— 
(A) upon the effective date of such final regulations; 
or 
(B) upon the expiration of such 18-month period if 
the final regulations have not been made effective as of 
the expiration of such period, subject to compliance with 
the final regulations when the final regulations are made 
effective. 
(2) DEFAULT; MINIMUM PERIOD OF ADVANCE NOTICE.—If 
under paragraph (1) the requirement for providing notice in 
accordance with section 801(m) of the Federal Food, Drug, 
and Cosmetic Act t£ikes effect without final regulations having 
been made effective, then for purposes of such requirement, 
the specified period of time that the notice is required to be 
made in advance of the time of the importation of the article 
of food involved or the offering of the food for import shedl 
be not fewer than eight hours Eind not more than five days, 
which shall remain in effect until the final regulations are 
made effective. 
SEC. 308. AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO 
UNITED STATES. 
(a) IN GENERAL.—Section 801 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)), as amended by section 307(a) 
of this Act, is amended by adding at the end the following: 
"(n)(l) If a food has been refused admission under subsection 
(a), other than such a food that is required to be destroyed, the 
Secretary may require the owner or consignee of the food to affix 
to the container of the food a label that clearly and conspicuously 
bears the statement: 'UNITED STATES: REFUSED ENTRV. 
"(2) All expenses in connection with affixing a label under 
paragraph (1) shall be paid by the owner or consignee of the 
food involved, and in default of such payment, shsdl constitute 
a lien against future importations made by such owner or consignee. 
"(3) A requirement under paragraph (1) remains in effect until 
the Secretary determines that the food involved has been brought 
into compliance with this Act.". 
(b) MISBRANDED FOODS.—Section 403 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding 
at the end the following: 
"(v) If— 
"(1) it fails to bear a label required by the Secretary under 
section 801(n)(l) (relating to food refused admission into the 
United States); 
PUBLIC LAW 1 0 7 - 1 8 8 - J U N E 12, 2002 
116 STAT. 673 
"(2) the Secretary finds that the food presents a threat 
of serious adverse health consequences or death to humans 
or animals; and 
"(3) upon or after notifying the owner or consignee involved 
that the label is required under section 801, the Secretary 
informs the owner or consignee that the food presents such 
a threat.". 
(c) RULE OF CONSTRUCTION.—^With respect to articles of food 
21 use 381 note, 
that are imported or offered for import into the United States, 
nothing in this section shall be construed to limit the authority 
of the Secretary of Health and Human Services or the Secretary 
of the Treasury to require the marking of refused articles of food 
under any other provision of law. 
SEC. 309. PROHIBITION AGAINST PORT SHOPPING. 
Section 402 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 342) is amended by adding at the end the following: 
"(h) If it is an article of food imported or offered for import 
into the United States and the article of food has previously been 
refused admission under section 801(a), unless the person reoffering 
the article affirmatively establishes, at the expense of the owner 
or consignee of the article, that the article complies with the 
applicable requirements of this Act, as determined by the Sec-
retary.". 
SEC. 310. NOTICES TO STATES REGARDING IMPORTED FOOD. 
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 391 et seq.) is amended by adding at the end the following 
section: 
"SEC. 908. NOTICES TO STATES REGARDING IMPORTED FOOD. 
21USC 398. 
"(a) IN GENERAL.—If the Secretary has credible evidence or 
information indicating that a shipment of imported food or portion 
thereof presents a threat of serious adverse health consequences 
or death to humans or animals, the Secretary shall provide notice 
regarding such threat to the States in which the food is held 
or will be held, and to the States in which the manufacturer, 
packer, or distributor of the food is located, to the extent that 
the Secretary has knowledge of which States are so involved. In 
providing notice to a State, the Secretary shall request the State 
to take such action as the State considers appropriate, if any, 
to protect the public health regarding the food involved. 
"(b) RULE OF CONSTRUCTION.—Subsection (a) may not be con-
strued as limiting the authority of the Secretary with respect to 
food under any other provision of this Act.". 
SEC. 311. GRANTS TO STATES FOR INSPECTIONS. 
Chapter IX of the Federal Food, Drug, and Cosmetic Act, as 
amended by section 310 of this Act, is amended by adding at 
the end the following section: 
"SEC. 909. GRANTS TO STATES FOR INSPECTIONS. 
21USC399. 
"(a) IN GENERAL.—^The Secretary is authorized to make grsmts 
to States, territories, and Indian tribes (as defined in section 4(e) 
of the Indian Self-Determination and Education Assistance Act 
(25 U.S.C. 450b(e))) that undertake examinations, inspections, and 
investigations, and related activities under section 702. The funds 
provided under such grants shall only be available for the costs 
116 STAT. 674 
PUBLIC LAW 107-188—JUNE 12, 2002 
of conducting such examinations, inspections, investigations, and 
related activities. 
"(b) NOTICES REGARDING ADULTERATED IMPORTED FOOD.—The 
Secretary may make grants to the States for the purpose of assisting 
the States with the costs of taking appropriate action to protect 
the pubUc health in response to notification under section 908, 
including planning and otherwise preparing to take such action. 
"(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
$10,000,000 for fiscal year 2002, and such sums as may be necessary 
for each of the fiscal years 2003 through 2006.". 
SEC. 312. SURVEILLANCE AND INFORMATION GRANTS AND AUTHORI-
TIES. 
Part B of title III of the Public Health Service Act (42 U.S.C. 
243 et seq.) is amended by inserting after section 317P the following: 
42 u s e 247b-20. 
"SEC. 317R. FOOD SAFETY GRANTS. 
"(a) IN GENERAL.—^The Secretary may award grants to States 
and Indian tribes (as defined in section 4(e) of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 450b(e))) 
to expand participation in networks to enhance Federal, State, 
and local food safety efforts, including meeting the costs of estab-
lishing and maintaining the food safety surveillance, technical, and 
laboratory capacity needed for such participation. 
"(b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
$19,500,000 for fiscal year 2002, and such sums as may be necessary 
for each of the fiscal years 2003 through 2006.". 
7 u s e 8319. 
SEC. 313. SURVEILLANCE OF ZOONOTIC DISEASES. 
The Secretary of Health and Human Services, through the 
Commissioner of Food and Drugs and the Director of the Centers 
for Disease Control and Prevention, and the Secretary of Agriculture 
shall coordinate the surveillance of zoonotic diseases. 
SEC, 314. AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS 
TO CONDUCT INSPECTIONS. 
Section 702(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 372(a)) is amended— 
(1) by striking "(a)" and inserting "(a)(1)"; 
(2) by striking "In the case of food packed" and inserting 
the following: 
"(3) In the case of food packed"; 
(3) by striking "For the purposes of this subsection" and 
inserting the following: 
"(4) For the purposes of this subsection,"; and 
(4) by inserting after paragraph (1) (as designated by para-
graph (1) of this section) the following paragraph: 
"(2)(A) In addition to the authority established in paragraph 
(1), the Secretary, pursuant to a memorandum of understanding 
between the Secretary and the head of another Federal department 
or agency, is authorized to conduct examinations and investigations 
for the purposes of this Act through the officers and employees 
of such other department or agency, subject to subparagraph (B). 
Such a memorandum shall include provisions to ensure adequate 
training of such officers and employees to conduct the examinations 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 675 
and investigations. The memorandum of understanding shall con-
tain provisions regarding reimbursement. Such provisions may, at 
the sole discretion of the head of the other department or agency, 
require reimbursement, in whole or in part, from the Secretary 
for the examinations or investigations performed under this section 
by the officers or employees of the other department or agency. 
"(B) A memorandum of understanding under subparagraph (A) 
between the Secretary £ind another Federal department or agency 
is effective only in the case of examinations or inspections at facili-
ties or other locations that are jointly regulated by the Secretary 
and such department or agency. 
"(C) For any fiscal year in which the Secretary and the head Reports, 
of another Federal department or agency carries out one or more 
examinations or inspections under a memorandum of understanding 
under subparagraph (A), the Secretary and the head of such depart-
ment or agency shall with respect to their respective departments 
or agencies submit to the committees of jurisdiction (authorizing 
and appropriating) in the House of Representatives and the Senate 
a report that provides, for such year— 
"(i) the number of officers or employees that carried out 
one or more programs, projects, or activities under such memo-
randum; 
"(ii) the number of additional articles that were inspected 
or examined as a result of such memorandum; and 
"(iii) the number of additional examinations or investiga-
tions that were carried out pursuant to such memorandum.". 
SEC. 315. RULE OF CONSTRUCTION. 
21USC 331 note. 
Nothing in this title, or an amendment made by this title, 
shall be construed to alter the jurisdiction between the Secretaries 
of Agriculture and of Health and Human Services, under applicable 
statutes and regulations. 
Subtitle B—Protection of Drug Supply 
SEC. 321. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS; 
SHIPPING INFORMATION; DRUG AND DEVICE LISTING. 
(a) ANNUAL REGISTRATION; LISTING.—Section 510 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C, 360) is amended— 
(1) in subsection (i)(l)— 
(A) by striking "Any establishment" and inserting "On 
or before December 31 of each year, any establishment"; 
and 
(B) by striking "shall register" and all that follows 
and inserting the following: "shall, through electronic 
means in accordance with the criteria of the Secretary, 
register with the Secretary the name and place of business 
of the establishment, the name of the United States agent 
for the establishment, the name of each importer of such 
drug or device in the United States that is known to 
the establishment, and the name of each person who 
imports or offers for import such drug or device to the 
United States for purposes of importation."; and 
(2) in subsection (j)(l), in the first sentence, by striking 
"or (d)" and inserting "(d), or (i)". 
116 STAT. 676 
PUBLIC LAW 107-188-JUNE 12, 2002 
(b) IMPORTATION; STATEMENT REGARDING REGISTRATION OF 
MANUFACTURER.— 
(1) IN GENERAL.—Section 801 of the Federal Food, Drug, 
and Cosmetic Act, as amended by section 308(a) of this Act, 
is amended by adding at the end the following subsection: 
"(o) If an article that is a drug or device is being imported 
or offered for import into the United States, and the importer, 
owner, or consignee of such article does not, at the time of offering 
the article for import, submit to the Secretary a statement that 
identifies the registration under section 510(i) of each establishment 
that with respect to such article is required under such section 
to register with the Secretary, the article may be refused admission. 
If the article is refused admission for failure to submit such a 
statement, the article shall be held at the port of entry for the 
article, and may not be delivered to the importer, owner, or con-
signee of the article, until such a statement is submitted to the 
Secretary. Subsection (b) does not authorize the delivery of the 
article pursuant to the execution of a bond while the article is 
so held. The article shall be removed to a secure facility, as appro-
priate. During the period of time that such article is so held, 
the article shall not be transferred by any person from the port 
of entry into the United States for the article, or from the secure 
facility to which the article has been removed, as the case may 
be.". 
(2) PROHIBITED ACT.—Section 301 of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 307(b) of this 
Act, is amended by adding at the end the following: 
"(fD The importing or offering for import into the United States 
of a drug or device with respect to which there is a failure to 
comply with a request of the Secretary to submit to the Secretary 
a statement under section 801(o).". 
21 use 331 note. 
(c) EFFECTIVE DATE.—^The amendments made by this section 
take effect upon the expiration of the 180-day period beginning 
on the date of the enactment of this Act. 
SEC. 322. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING 
IMPORT COMPONENTS INTENDED FOR USE IN EXPORT 
PRODUCTS. 
(a) IN GENERAL.—Section 801(d)(3) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to read as 
follows: 
"(3)(A) Subject to subparagraph (B), no component of a drug, 
no component part or accessory of a device, or other article of 
device requiring further processing, which is ready or suitable for 
use for health-related purposes, and no article of a food additive, 
color additive, or dietary supplement, including a product in bulk 
form, shall be excluded from importation into the United States 
under subsection (a) if each of the following conditions is met: 
"(i) The importer of such article of a drug or device or 
importer of such article of a food additive, color additive, or 
dietary supplement submits to the Secretary, at the time of 
initial importation, a statement in accordance with the fol-
lowing: 
"(I) Such statement provides that such article is 
intended to be further processed by the initial owner or 
consignee, or incorporated by the initial owner or consignee, 
into a drug, biological product, device, food, food additive. 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
116 STAT. 677 
color additive, or dietary supplement that will be exported 
by the initial owner or consignee from the United States 
in accordance with subsection (e) or section 802, or with 
section 351(h) of the Public Health Service Act. 
"(II) The statement identifies the manufacturer of such 
article and each processor, packer, distributor, or other 
entity that had possession of the article in the chain of 
possession of the article from the manufacturer to such 
importer of the article. 
"(Ill) The statement is accompanied by such certificates 
of analysis as are necessary to identify such article, unless 
the article is a device or is an article described in paragraph 
(4). 
"(ii) At the time of initial importation and before the 
delivery of such article to the importer or the initial owner 
or consignee, such owner or consignee executes a good and 
sufficient bond providing for the payment of such liquidated 
damages in the event of default as may be required pursuant 
to regulations of the Secretary of the Treasury. 
"(iii) Such article is used and exported by the initial owner 
or consignee in accordance with the intent described under 
clause (i)(I), except for any portions of the article that are 
destroyed. 
"(iv) The initial owner or consignee maintgdns records on Records. 
the use or destruction of such article or portions thereof, as 
the case may be, and submits to the Secretary any such records 
requested by the Secretary. 
"(v) Upon request of the Secretary, the initial owner or Reports. 
consignee submits a report that provides an accounting of the 
exportation or destruction of such article or portions thereof, 
and the manner in which such owner or consignee complied 
with the requirements of this subparagraph. 
"(B) Notwithstanding subparagraph (A), the Secretary may 
refuse admission to an article that otherwise would be imported 
into the United States under such subparagraph if the Secretary 
determines that there is credible evidence or information indicating 
that such article is not intended to be further processed by the 
initial owner or consignee, or incorporated by the initial owner 
or consignee, into a drug, biological product, device, food, food 
additive, color additive, or dietary supplement that will be exported 
by the initial owner or consignee from the United States in accord-
ance with subsection (e) or section 802, or with section 351(h) 
of the Public Health Service Act. 
"(C) This section may not be construed as affecting the responsi-
bility of the Secretary to ensure that articles imported into the 
United States under authority of subparagraph (A) meet each of 
the conditions established in such subparagraph for importation.". 
(b) PROHIBITED ACT.—Section 301(w) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 331(w)) is amended to read as follows: 
"(w) The making of a knowingly false statement in any state-
ment, certificate of analysis, record, or report required or requested 
under section 801(d)(3); the failure to submit a certificate of analysis 
as required under such section; the failure to maintain records 
or to submit records or reports as required by such section; the 
release into interstate commerce of any article or portion thereof 
imported into the United States under such section or any finished 
product made from such article or portion, except for export in 
116 STAT. 678 
PUBLIC LAW 107-188-^UNE 12, 2002 
accordance with section 801(e) or 802, or with section 351(h) of 
the PubUc Health Service Act; or the failure to so export or to 
destroy such an article or portions thereof, or such a finished 
product.". 
21 use 331 note. 
(c) EFFECTIVE DATE.—^The amendments made by this section 
take effect upon the expiration of the 90-day period beginning 
on the date of the enactment of this Act. 
Subtitle C—General Provisions Relating to 
Upgrade of Agricultural Security 
7 use 8320. 
SEC. 331. EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION 
SERVICE ACTIVITIES. 
(a) IN GENERAL.—^The Secretary of Agriculture (referred to 
in this section as the "Secretary") may utilize existing authorities 
to give high priority to enhancing and expanding the capacity 
of the Animal and Plant Health Inspection Service to conduct 
activities to— 
(1) increase the inspection capacity of the Service at inter-
national 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) develop new and improve existing strategies and tech-
nologies for dealing with intentional outbreaks of plant and 
animal disease arising from acts of terrorism or from uninten-
tional introduction, including— 
(A) establishing cooperative agreements among Veteri-
nary Services of the Animal and Plant Health Inspection 
Service, State animal health commissions and regulatory 
agencies for livestock and poultry health, and private vet-
erinary practitioners to enhance the preparedness and 
ability of Veterinary Services and the commissions and 
agencies to respond to outbreaks of such animal diseases; 
and 
(B) strengthening planning and coordination 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 improve the capacity of the Service to protect 
against the threat of bioterrorism. 
(b) AUTOMATED RECORDKEEPING SYSTEM.—The Administrator 
of the Animal and Plant Health Inspection Service may implement 
a central automated recordkeeping system to provide for the reliable 
tracking of the status of animal and plant shipments, including 
those shipments on hold at ports of entry and customs. The Sec-
retary shall ensure that such a system shall be fully accessible 
to or fully integrated with the Food Safety Inspection Service. 
(c) 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. 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 679 
SEC. 332. EXPANSION OF FOOD SAFETY INSPECTION SERVICE ACTIVI- 
21 USC 679c. 
TIES. 
(a) IN GENERAL.—The Secretary of Agriculture may utilize 
existing authorities to give high priority to enhEincing and 
expanding the capacity of the Food Safety Inspection Service to 
conduct activities to— 
(1) enhance the ability of the Service to inspect and ensure 
the safety £uid wholesomeness of meat and poultry products; 
(2) improve the capacity of the Service to inspect inter-
national 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 collaborate with 
relevant agencies within the Department of Agriculture and 
with other entities in the Federal Grovemment, the States, 
£ind Indigm tribes (as defined in section 4(e) of the Indian 
Self-Determination and Education Assistance Act (25 U.S.C. 
450b(e))) 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. 333. BIOSECURITY UPGRADES AT THE DEPARTMENT OF AGRI- Appropriation 
CULTURE. 
authorization. 
State listing. 
There is authorized to be appropriated for fiscal year 2002, 
$180,000,000 for the purpose of enabling the AgriculturgJ Research 
Service to conduct building upgrades to modernize existing facilities, 
of which (1) $100,000,000 shall be allocated for renovation, 
updating, and expansion of the Bioseifety Level 3 laboratory and 
animal research facilities at the Plum Island Animal Disease Center 
(Greenport, New York), and of which (2) $80,000,000 shall be allo-
cated for the Agricultural Research Service/Animal and Plant 
Health Inspection Service facility in Ames, Iowa. There are author-
ized to be appropriated such sums as may be necessary for fiscal 
years 2003 through 2006 for the purpose described in the preceding 
sentence, for the planning and design of an Agricultural Research 
Service biocontsdnment laboratory for poultry research in Athens, 
Georgia, and for the plsuining, updating, and renovation of the 
Arthropod-Borne Animal Disease Laboratory in Laramie, Wyoming. 
SEC. 334. AGRICULTURAL BIOSECURITY. 
7 USC 3353. 
(a) SECURITY AT COLLEGES AND UNIVERSITIES.— 
(1) GRANTS.—The Secretary of Agriculture (referred to in 
this section as the "Secretary") may award grants to covered 
entities to review security standards and practices at their 
facilities in order to protect against bioterrorist attacks. 
(2) COVERED ENTITIES.—Covered entities under this sub-
section are colleges or universities that— 
(A) are colleges or universities as defined in section 
1404 of the National Agricultural Research, Extension, and 
Teaching PoHcy Act of 1977 (7 U.S.C. 3103); and 
(B) have programs in food and agricultural sciences, 
as defined in such section. 
99-194 O - 03 - 23 :QL 3 Parti 
116 STAT. 680 
PUBLIC LAW 107-188-^UNE 12, 2002 
(3) LIMITATION,—Each individual covered entity may be 
awarded one grant under paragraph (1), the amount of which 
shall not exceed $50,000. 
(4) 
CONTRACT 
AUTHORITY.—Colleges 
and 
universities 
receiving grants under paragraph (1) may use such grants 
to enter into contracts with independent private organizations 
with established and demonstrated security expertise to conduct 
the security reviews specified in such paragraph. 
(b) GUIDELINES FOR AGRICULTURAL BIOSECURITY.— 
(1) IN GENERAL.—The Secretary may award grants to 
associations of food producers or consortia of such associations 
for the development and implementation of educational pro-
grams to improve biosecurity on farms in order to ensure the 
security of farm facilities against potential bioterrorist attacks. 
(2) LIMITATION.—Each individual association eligible under 
paragraph (1) may be awarded one grant under such paragraph, 
the amount of which shall not exceed $100,000. Each consor-
tium eligible under paragraph (1) may be awarded one grant 
under such paragraph, the amount of which shall not exceed 
$100,000 per association participating in the consortium. 
(3) CONTRACT AUTHORITY.—^Associations of food producers 
receiving grants under paragraph (1) may use such grants 
to enter into contracts with independent private organizations 
with established and demonstrated expertise in biosecurity to 
assist in the development and implementation of educational 
programs to improve biosecurity specified in such paragraph. 
(c) AUTHORIZATION OF APPROPRL^TIONS.—There are authorized 
to be appropriated to carry out this section such sums as may 
be necessary for each fiscal year. 
7 use 3354. 
SEC. 335. AGRICULTURAL BIOTERRORISM RESEARCH AND DEVELOP-
MENT. 
(a) IN GENERAL.—^The Secretary of Agriculture (referred to 
in this section as the "Secretary") may utilize existing research 
authorities and research programs to protect the food supply of 
the United States by conducting and supporting research activities 
to— 
(1) enhance the capability of the Secretary to respond in 
a timely manner to emerging or existing bioterrorist threats 
to the food and agricultural system of the United States; 
(2) develop new and continue partnerships with institutions 
of higher education and other institutions to help form stable, 
long-term programs to enhance the biosecurity and food safety 
of the United States, including the coordination of the develop-
ment, implementation, and enhancement of diverse capabilities 
for addressing threats to the nation's agricultural economy 
and food supply, with special emphasis on planning, training, 
outreach, and research activities related to vulnerability anal-
yses, incident response, detection, and prevention technologies; 
(3) strengthen coordination with the intelligence commu-
nity to better identify research needs and evaluate materials 
or information acquired by the intelligence community relating 
to potential threats to United States agriculture; 
(4) expand the involvement of the Secretary with inter-
national organizations dealing with plant and animal disease 
control; 
PUBLIC LAW 107-188-JUNE 12, 2002 
116 STAT. 681 
(5) continue research to develop rapid detection field test 
kits to detect biological threats to plants and animals and 
to provide such test kits to State and local agencies preparing 
for or responding to bioterrorism; 
(6) develop an agricultural bioterrorism early warning 
surveillance system through enhancing the capacity of and 
coordination between State veterinary diagnostic laboratories, 
Federal and State agricultural research facilities, and public 
health agencies; and 
(7) otherwise improve the capacity of the Secretary to pro-
tect 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. 
SEC. 336. ANIMAL ENTERPRISE TERRORISM PENALTIES. 
(a) IN GENERAL.—Section 43(a) of title 18, United States Code, 
is amended to read as follows: 
"(a) OFFENSE.—^Whoever— 
"(1) travels in interstate or foreign commerce, or uses or 
causes to be used the mail or any facility in interstate or 
foreign commerce for the purpose of causing physical disruption 
to the functioning of an animal enterprise; and 
"(2) intentionally damages or causes the loss of any prop-
erty (including animals or records) used by the animal enter-
prise, or conspires to do so, 
shall be punished as provided for in subsection (b).". 
(b) PENALTIES.—Section 43(b) of title 18, United States Code, 
is amended to read as follows: 
"(b) PENALTIES.— 
"(1) ECONOMIC DAMAGE.—Any person who, in the course 
of a violation of subsection (a), causes economic damage not 
exceeding $10,000 to an animal enterprise shall be fined under 
this title or imprisoned not more than 6 months, or both. 
"(2) MAJOR ECONOMIC DAMAGE.—^Any person who, in the 
course of a violation of subsection (a), causes economic damage 
exceeding $10,000 to an animal enterprise shall be fined under 
this title or imprisoned not more than 3 years, or both. 
"(3) SERIOUS BODILY INJURY.—^Any person who, in the 
course of a violation of subsection (a), causes serious bodily 
injury to another individual shall be fined under this title 
or imprisoned not more than 20 years, or both. 
"(4) DEATH.—^Any person who, in the course of a violation 
of subsection (a), causes the death of an individual shall be 
fined under this title and imprisoned for life or for any term 
of years.". 
(c) RESTITUTION.—Section 43(c) of title 18, United States Code, 
is amended— 
(1) in paragraph (1), by striking "and" at the end; 
(2) in paragraph (2), by striking the period at the end 
and inserting "; and"; and 
(3) by adding at the end the following: 
"(3) for any other economic damage resulting from the 
offense.". 
116 STAT. 682 
PUBLIC LAW 107-188-^UNE 12, 2002 
TITLE IV—DRINKING WATER SECURITY 
AND SAFETY 
42 u s e 300i-2. 
Deadline. 
Certification. 
Deadlines. 
Deadlines. 
Protocols. 
SEC. 
401. 
TERRORIST 
AND 
OTHER 
INTENTIONAL 
ACTS. 
The Safe Drinking Water Act (title XIV of the Public Health 
Service Act) is amended by inserting the following new section 
after section 1432: 
"SEC. 1433. TERRORIST AND OTHER INTENTIONAL ACTS. 
"(a) VULNERABILITY ASSESSMENTS.—(1) Each community water 
system serving a population of greater than 3,300 persons shall 
conduct an assessment of the vulnerability of its system to a ter-
rorist attack or other intentional acts intended to substantially 
disrupt the ability of the system to provide a safe and reliable 
supply of drinking water. The vulnerability assessment shall 
include, but not be limited to, a review of pipes and constructed 
conveyances, physical barriers, water collection, pretreatment, treat-
ment, storage and distribution facilities, electronic, computer or 
other automated systems which are utilized by the public water 
system, the use, storage, or handling of various chemicals, and 
the operation and maintenance of such system. The Administrator, 
not later than August 1, 2002, after consultation with appropriate 
departments and agencies of the Federal Government and with 
State and local governments, shall provide baseline information 
to community water systems required to conduct vulnerability 
assessments regarding which kinds of terrorist attacks or other 
intentional acts are the probable threats to— 
"(A) substantially disrupt the ability of the system to pro-
vide a safe and reliable supply of drinking water; or 
"(B) otherwise present significant public health concerns. 
"(2) Each community water system referred to in paragraph 
(1) shall certify to the Administrator that the system has conducted 
an assessment complying with paragraph (1) and shall submit 
to the Administrator a written copy of the assessment. Such certifi-
cation and submission shall be made prior to: 
"(A) March 31, 2003, in the case of systems serving a 
population of 100,000 or more. 
"(B) December 31, 2003, in the case of systems serving 
a population of 50,000 or more but less than 100,000. 
"(C) June 30, 2004, in the case of systems serving a popu-
lation greater than 3,300 but less than 50,000. 
"(3) Except for information contained in a certification under 
this subsection identifying the system submitting the certification 
and the date of the certification, all information provided to the 
Administrator under this subsection and all information derived 
therefrom shall be exempt from disclosure under section 552 of 
title 5 of the United States Code. 
"(4) No community water system shall be required under State 
or local law to provide an assessment described in this section 
to any State, regional, or local governmental entity solely by reason 
of the requirement set forth in paragraph (2) that the system 
submit such assessment to the Administrator. 
"(5) Not later than November 30, 2002, the Administrator, 
in consultation with appropriate Federal law enforcement and intel-
ligence officials, shall develop such protocols as may be necessary 
to protect the copies of the assessments required to be submitted 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 683 
under this subsection (and the information contained therein) from 
unauthorized disclosure. Such protocols shall ensure that— 
"(A) each copy of such assessment, and all information 
contained in or derived from the assessment, is kept in a 
secure location; 
"(B) only individuals designated by the Administrator may 
have access to the copies of the assessments; and 
"(C) no copy of an assessment, or part of an assessment, 
or information contained in or derived from an assessment 
shall be available to anyone other than an individual designated 
by the Administrator. 
At the earliest possible time prior to November 30, 2002, the 
Administrator shall complete the development of such protocols 
for the purpose of having them in place prior to receiving any 
vulnerability assessments from community water systems under 
this subsection. 
"(6)(A) Except as provided in subparagraph (B), any individual 
referred to in paragraph (5)(B) who acquires the assessment sub-
mitted under paragraph (2), or any reproduction of such assessment, 
or any information derived from such assessment, and who know-
ingly or recklessly reveals such assessment, reproduction, or 
information other than— 
"(i) to an individual designated by the Administrator under 
paragraph (5), 
"(ii) for purposes of section 1445 or for actions under section 
1431, or 
"(iii) for use in any administrative or judicial proceeding 
to impose a penalty for failure to comply with this section, 
shall upon conviction be imprisoned for not more than one year 
or fined in accordance with the provisions of chapter 227 of title 
18, United States Code, applicable to class A misdemeanors, or 
both, and shall be removed from Federal office or employment. 
"(B) Notwithstanding subparagraph (A), an individual referred 
to in paragraph (5)(B) who is an officer or employee of the United 
States may discuss the contents of a vulnerability assessment sub-
mitted under this section with a State or local official. 
"(7) Nothing in this section authorizes any person to withhold 
any information from Congress or from any committee or sub-
committee of Congress. 
"(b) EMERGENCY RESPONSE PLAN.—Each community water 
system serving a population greater than 3,300 shall prepare or 
revise, where necessary, an emergency response plan that incor-
porates the results of vulnerability assessments that have been 
completed. Each such community water system shall certify to Certification. 
the Administrator, as soon as reasonably possible after the enact- Deadline, 
ment of this section, but not later than 6 months after the comple-
tion of the vulnerability assessment under subsection (a), that the 
system has completed such plan. The emergency response plan 
shall include, but not be limited to, plans, procedures, and identifica-
tion of equipment that can be implemented or utilized in the event 
of a terrorist or other intentional attack on the public water system. 
The emergency response plan shall also include actions, procedures, 
and identification of equipment which can obviate or significantly 
lessen the impact of terrorist attacks or other intentional actions 
on the public health and the safety and supply of drinking water 
provided to communities and individuals. Community water systems 
116 STAT. 684 
PUBLIC LAW 107-188-^UNE 12, 2002 
shall, to the extent possible, coordinate with existing Local Emer-
gency Planning Committees established under the Emergency Plan-
ning and Community Right-to-Know Act (42 U.S.C. 11001 et seq.) 
when preparing or revising an emergency response plan under 
this subsection. 
"(c) RECORD MAINTENANCE.—Each community water system 
shall maintain a copy of the emergency response plan completed 
pursuant to subsection (b) for 5 years after such plan has been 
certified to the Administrator under this section. 
"(d) 
GUIDANCE 
TO SMALL 
PUBLIC 
WATER 
SYSTEMS.—The 
Administrator shall provide guidance to community water systems 
serving a population of less than 3,300 persons on how to conduct 
vulnerability assessments, prepare emergency response plans, and 
address threats from terrorist attacks or other intentional actions 
designed to disrupt the provision of safe drinking water or signifi-
cantly affect the public health or significantly affect the safety 
or supply of drinking water provided to communities and individ-
uals. 
"(e) FUNDING.—(1) There are authorized to be appropriated 
to carry out this section not more than $160,000,000 for the fiscal 
year 2002 and such sums as may be necessary for the fiscal years 
2003 through 2005. 
"(2) The Administrator, in coordination with State and local 
governments, may use funds made available under paragraph (1) 
to provide financial assistance to community water systems for 
purposes of compliance with the requirements of subsections (a) 
and (b) and to community water systems for expenses and contracts 
designed to address basic security enhancements of critical impor-
tance and significant threats to public health and the supply of 
drinking water as determined by a vulnerability assessment con-
ducted under subsection (a). Such basic security enhancements 
may include, but shall not be limited to the following: 
"(A) the purchase and installation of equipment for detec-
tion of intruders; 
"(B) the purchase and installation of fencing, gating, 
lighting, or security cameras; 
"(C) the tamper-proofing of manhole covers, fire hydrants, 
and valve boxes; 
"(D) the rekeying of doors and locks; 
"(E) improvements to electronic, computer, or other auto-
mated systems and remote security systems; 
"(F) participation in training programs, and the purchase 
of training manuals and guidance materials, relating to security 
against terrorist attacks; 
"(G) improvements in the use, storage, or handling of var-
ious chemicals; and 
"(H) security screening of employees or contractor support 
services. 
Funding under this subsection for basic security enhancements 
shall not include expenditures for personnel costs, or monitoring, 
operation, or maintenance of facilities, equipment, or systems. 
"(3) The Administrator may use not more than $5,000,000 
from the funds made available under paragraph (1) to make grants 
to community water systems to assist in responding to and alle-
viating any vulnerability to a terrorist attack or other intentional 
acts intended to substantially disrupt the ability of the system 
to provide a safe and reliable supply of drinking water (including 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
116 STAT. 685 
sources of water for such systems) which the Administrator deter-
mines to present an immediate and urgent security need. 
"(4) The Administrator may use not more than $5,000,000 
from the funds made available under paragraph (1) to make grants 
to community water systems serving a population of less than 
3,300 persons for activities and projects undertaken in accordance 
with the guidance provided to such systems under subsection (d). 
SEC. 402. OTHER SAFE DRINKING WATER ACT AMENDMENTS. 
The Safe Drinking Water Act (title XIV of the Public Health 
Service Act) is amended by inserting the following new sections 
after section 1433 (as added by section 401 of this Act): 
"SEC. 1434. CONTAMINANT PREVENTION, DETECTION AND RESPONSE. 
42 USC 300i-3. 
"(a) IN GENERAL.—The Administrator, in consultation with the Contracts. 
Centers for Disease Control and, after consultation with appropriate 
departments and agencies of the Federal Government and with 
State and local governments, shall review (or enter into contracts 
or cooperative agreements to provide for a review of) current and 
future methods to prevent, detect and respond to the intentional 
introduction of chemical, biological or radiological contaminants 
into community water systems and source water for community 
water systems, including each of the following: 
"(1) Methods, means and equipment, including real time 
monitoring systems, designed to monitor and detect various 
levels of chemical, biological, and radiological contaminants 
or indicators of contaminants and reduce the likelihood that 
such contaminants can be successfully introduced into public 
water systems and source water intended to be used for 
drinking water. 
"(2) Methods and means to provide sufficient notice to 
operators of public water systems, and individuals served by 
such systems, of the introduction of chemical, biological or 
radiological contaminants and the possible effect of such 
introduction on public health and the safety and supply of 
drinking water. 
"(3) Methods and means for developing educational and 
awareness programs for community water systems. 
"(4) Procedures and equipment necessary to prevent the 
flow of contaminated drinking water to individuals served by 
public water systems. 
"(5) Methods, means, and equipment which could negate 
or mitigate deleterious effects on public health and the safety 
and supply caused by the introduction of contaminants into 
water intended to be used for drinking water, including an 
examination of the effectiveness of various drinking water tech-
nologies in removing, inactivating, or neutralizing biological, 
chemical, and radiological contaminants. 
"(6) Biomedical research into the short-term and long-term 
impact on public health of various chemical, biological and 
radiological contaminants that may be introduced into public 
water systems through terrorist or other intentional acts. 
"(b) FUNDING.—For the authorization of appropriations to carry 
out this section, see section 1435(e). 
116 STAT. 686 
PUBLIC LAW 107-188-^UNE 12, 2002 
42USC300i-4. 
"SEC. 1435. SUPPLY DISRUPTION PREVENTION, DETECTION AND 
RESPONSE. 
Contracts. 
"(a) DISRUPTION OF SUPPLY OR SAFETY.—The Administrator, 
in coordination with the appropriate departments and agencies 
of the Federal Government, shall review (or enter into contracts 
or cooperative agreements to provide for a review of) methods 
and means by which terrorists or other individuals or groups could 
disrupt the supply of safe drinking water or take other actions 
against water collection, pretreatment, treatment, storage and dis-
tribution facilities which could render such water significantly less 
safe for human consumption, including each of the following: 
"(1) Methods and means by which pipes and other con-
structed conveyances utilized in public water systems could 
be destroyed or otherwise prevented from providing adequate 
supplies of drinking water meeting applicable public health 
standards. 
"(2) Methods and means by which collection, pretreatment, 
treatment, storage and distribution facilities utilized or used 
in connection with public water systems and collection and 
pretreatment storage facilities used in connection with public 
water systems could be destroyed or otherwise prevented from 
providing 
adequate 
supplies 
of drinking water 
meeting 
applicable public health standards. 
"(3) Methods and means by which pipes, constructed 
conveyances, collection, pretreatment, treatment, storage and 
distribution systems that are utilized in connection with public 
water systems could be altered or affected so as to be subject 
to cross-contamination of drinking water supplies. 
"(4) Methods and means by which pipes, constructed 
conveyances, collection, pretreatment, treatment, storage and 
distribution systems that are utilized in connection with public 
water systems could be reasonably protected from terrorist 
attacks or other acts intended to disrupt the supply or affect 
the safety of drinking water. 
"(5) Methods and means by which information systems, 
including process controls and supervisory control and data 
acquisition and cyber systems at community water systems 
could be disrupted by terrorists or other groups. 
"(b) ALTERNATIVE SOURCES.—The review under this section 
shall also include a review of the methods and means by which 
alternative supplies of drinking water could be provided in the 
event of the destruction, impairment or contamination of public 
water systems. 
"(c) REQUIREMENTS AND CONSIDERATIONS.—In carrying out this 
section and section 1434— 
"(1) the Administrator shall ensure that reviews carried 
out under this section reflect the needs of community water 
systems of various sizes and various geographic areas of the 
United States; and 
"(2) the Administrator may consider the vulnerability of, 
or potential for forced interruption of service for, a region 
or service area, including community water systems that pro-
vide service to the National Capital area. 
"(d) INFORMATION SHARING.—^As soon as practicable 
after 
reviews carried out under this section or section 1434 have been 
evaluated, the Administrator shall disseminate, as appropriate as 
determined by the Administrator, to community water systems 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 687 
information on the results of the project through the Information 
Sharing and Analysis Center, or other appropriate means. 
"(e) FUNDING.—There are authorized to be appropriated to carry 
out this section and section 1434 not more than $15,000,000 for 
the fiscal year 2002 and such sums as may be necessary for the 
fiscal years 2003 through 2005.". 
SEC. 403. MISCELLANEOUS AND TECHNICAL AMENDMENTS. 
The Safe Drinking Water Act is amended as follows: 
(1) Section 1414(i)(l) is amended by inserting "1433" after 
"1417". 
(2) Section 1431 is amended by inserting in the first sen-
tence after "drinking water" the following: ", or that there 
is a threatened or potential terrorist attack (or other intentional 
act designed to disrupt the provision of safe drinking water 
or to impact adversely the safety of drinking water supplied 
to communities and individuals), which". 
(3) Section 1432 is amended as follows: 
(A) By striking "5 years" in subsection (a) and inserting 
"20 years". 
(B) By striking "3 years" in subsection (b) and inserting 
"10 years". 
(C) By striking "$50,000" in subsection (c) and inserting 
"$1,000,000". 
(D) By striking "$20,000" in subsection (c) and 
inserting "$100,000". 
(4) Section 1442 is amended as follows: 
(A) By striking "this subparagraph" in subsection (b) 
and inserting "this subsection". 
(B) By amending subsection (d) to read as follows: 
"(d) There are authorized to be appropriated to carry out sub-
section (b) not more than $35,000,000 for the fiscal year 2002 
and such sums as may be necessary for each fiscal year thereafter.". 
TITLE V—ADDITIONAL PROVISIONS 
42 use 300g-3. 
42 use 300i. 
42 use 300i-l. 
42 use 300J-1. 
Appropriation 
authorization. 
Subtitle A—Prescription Drug User Fees 
SEC. 501. SHORT TITLE. 
This subtitle may be cited as the "Prescription Drug User 
Fee Amendments of 2002". 
SEC. 502. FINDINGS. 
The Congress finds that— 
(1) prompt approval of safe and effective new drugs and 
other therapies is critical to the improvement of the public 
health so that patients may enjoy the benefits provided by 
these therapies to treat and prevent illness and disease; 
(2) the public health will be served by making additional 
funds available for the purpose of augmenting the resources 
of the Food and Drug Administration that are devoted to the 
process for the review of human drug applications and the 
. assurance of drug safety; 
(3) the provisions added by the Prescription Drug User 
Fee Act of 1992, as amended by the Food and Drug Administra-
tion Modernization Act of 1997, have been successful in 
Prescription 
Drug User Fee 
Amendments of 
2002. 
21 use 301 note. 
21 use 379g 
note. 
116 STAT. 688 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
substantially reducing review times for human drug applica-
tions and should be— 
(A) reauthorized for an additional 5 years, with certain 
technical improvements; and 
(B) carried out by the Food and Drug Administration 
with new commitments to implement more ambitious and 
comprehensive improvements in regulatory processes of the 
Food and Drug Administration, including— 
(i) strengthening and improving the review and 
monitoring of drug safety; 
(ii) considering greater interaction between the 
agency and sponsors during the review of drugs and 
biologies intended to treat serious diseases and life-
threatening diseases; and 
(iii) developing principles for improving first-cycle 
reviews; and 
(4) the fees authorized by amendments made in this subtitle 
will be dedicated towards expediting the drug development 
process and the process for the review of human drug applica-
tions as set forth in the goals identified for purposes of part 
2 of subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act, in the letters from the Secretary of Health 
and Human Services to the chairman of the Committee on 
Energy and Commerce of the House of Representatives and 
the chairman of the Committee on Health, Education, Labor 
and Pensions of the Senate, as set forth in the Congressional 
Record. 
SEC. 503. DEFINITIONS. 
Section 735 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379g) is amended— 
(1) in paragraph (1), in the matter after and below subpara-
graph (C), by striking "licensure, as described in subparagraph 
(D)" and inserting "licensure, as described in subparagraph 
(C)"; 
(2) in paragraph (3)— 
(A) in subparagraph (A), by striking "and" at the end; 
(B) in subparagraph (B), by striking the period and 
inserting ", and"; 
(C) by inserting after subparagraph (B) the following 
subparagraph: 
"(C) which is on the list of products described in section 
505(j)(7)(A) or is on a list created and maintained by the 
Secretary of products approved under human drug applica-
tions under section 351 of the Public Health Service Act."; 
and 
(D) in the matter after and below subparagraph (C) 
(as added by subparagraph (C) of this paragraph), by 
striking "Service Act," and all that follows through 
"biological product" and inserting the following: "Service 
Act. Such term does not include a biological product"; 
(3) in paragraph (6), by adding at the end the following 
subparagraph: 
"(F) In the case of drugs approved after October 1, 
2002, under human drug applications or supplements: col-
lecting, developing, and reviewing safety information on 
the drugs, including adverse event reports, during a period 
PUBLIC LAW 1 0 7 - 1 8 8 - ^ U N E 12, 2002 
116 STAT. 689 
of time after approval of such applications or supplements, 
not to exceed three years."; and 
(4) in paragraph (8>— 
(A) by striking the matter after and below subpara-
graph (B); 
(B) by striking subparagraph (B); 
(C) by striking "is the lower of' and all that follows 
through "Consumer Price Index" and inserting "is the Con-
sumer Price Index"; and 
(D) by striking "1997, or" and inserting "1997.". 
SEC. 504. AUTHORITY TO ASSESS AND USE DRUG FEES. 
(a) TYPES OF FEES.—Section 736(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(a)) is amended— 
(1) in the matter preceding paragraph (1), by striking "fiscal 
year 1998" and inserting "fiscal year 2003"; 
(2) in paragraph (1)(A)— 
(A) in each of clauses (i) and (ii), by striking "in sub-
section (b)" and inserting "under subsection (c)(4)"; and 
(B) in clause (ii), by adding at the end the following 
sentence: "Such fee shall be half of the amount of the 
fee established under clause (i)."; 
(3) in paragraph (2)(A), in the matter after and below 
clause (ii)— 
(A) by striking "in subsection (b)" and inserting "under 
subsection (c)(4)"; and 
(B) by striking "payable on or before January 31" and 
inserting "payable on or before October 1"; and 
(4) in paragraph (3)— 
(A) by amending subparagraph (A) to read as follows: 
"(A) IN GENERAL.—Except as provided in subparagraph 
(B), each person who is named as the applicant in a human 
drug application, and who, after September 1, 1992, had 
pending before the Secretary a human drug application 
or supplement, shall pay for each such prescription drug 
product the annual fee established under subsection (c)(4). 
Such fee shall be payable on or before October 1 of each 
year. Such fee shall be paid only once for each product 
for a fiscal year in which the fee is payable."; and 
(B) in subparagraph (B), by striking "The listing" and 
all that follows through "filed under section 505(b)(2)" and 
inserting the following: "A prescription drug product shall 
not be assessed a fee under subparagraph (A) if such 
product is identified on the list compiled under section 
505(j)(7)(A) with a potency described in terms of per 100 
mL, or if such product is the same product as another 
product approved under an application filed under section 
505(b)". 
(b) FEE AMOUNTS.—Section 736(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows: 
"(b) FEE REVENUE AMOUNTS.—Except as provided in sub-
sections (c), (d), (f), and (g), fees under subsection (a) shall be 
established to generate the following revenue amounts: 
s 
116 STAT. 690 
PUBLIC LAW 1 0 7 - 1 8 8 - J U N E 12, 2002 
'Type of Fee Rev-
enue 
Application/Sup-
Establishment 
Product 
Total Fee Revenue 
Fiscal Year 
2003 
$74,300,000 
$74,300,000 
$74,300,000 
$222,900,000 
Fiscal Year 
2004 
$77,000,000 
$77,000,000 
$77,000,000 
$231,000,000 
Fiscal Year 
2005 
$84,000,000 
$84,000,000 
$84,000,000 
$252,000,000 
Fiscal Year 
2006 
$86,434,000 
$86,433,000 
$86,433,000 
$259,300,000 
Fiscal Year 
2007 
$86,434,000 
$86,433,000 
$86,433,000 
$259,300,000 
Effective date. 
Federal Register, 
publication. 
If, after the date of the enactment of the Prescription Drug User 
Fee Amendments of 2002, legislation is enacted requiring the Sec-
retary to fund additional costs of the retirement of Federal per-
sonnel, fee revenue amounts shall be increased in each year by 
the amount necessary to fully fund the portion of such additional 
costs that are attributable to the process for the review of human 
drug applications.". 
(c) ADJUSTMENTS.—Section 736(c) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(c)) is amended— 
(1) in paragraph (1)— 
(A) in the matter preceding subparagraph (A), by 
striking "fees and total fee revenues" and inserting "reve-
nues"; 
(B) in subparagraph (A)— 
(i) by striking "during the preceding fiscal year"; 
and 
(ii) by striking ", or" and inserting the following: 
"for the 12 month period ending June 30 preceding 
the fiscal year for which fees are being established, 
or ; 
(C) in subparagraph (B), by striking "for such fiscal 
year" and inserting "for the previous fiscal year"; and 
(D) in the matter after and below subparagraph (B), 
by striking "fiscal year 1997"; and inserting "fiscal year 
2003"; 
(2) by redesignating paragraphs (2) and (3) as paragraphs 
(4) and (5), respectively; 
(3) by inserting after paragraph (1) the following para-
graphs: 
"(2) WORKLOAD ADJUSTMENT.—Beginning with fiscal year 
2004, after the fee revenues established in subsection (b) are 
adjusted for a fiscal year for inflation in accordance with para-
graph (1), the fee revenues shall be adjusted further for such 
fiscal year to reflect changes in the workload of the Secretary 
for the process for the review of human drug applications. 
With respect to such adjustment: 
"(A) The adjustment shall be determined by the Sec-
retary based on a weighted average of the change in the 
total number of human drug applications, commercial 
investigational new drug applications, efficacy supple-
ments, and manufacturing supplements submitted to the 
Secretary. The Secretary shall publish in the Federal Reg-
ister the fee revenues and fees resulting from the adjust-
ment and the supporting methodologies. 
"(B) Under no circumstances shall the adjustment 
result in fee revenues for a fiscal year that are less than 
the fee revenues for the fiscal year established in subsection 
(b), as adjusted for inflation under paragraph (1). 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 691 
"(3) FINAL YEAR ADJUSTMENT.—^For fiscal year 2007, the 
Secretary may, in addition to adjustments under paragraphs 
(1) and (2), further increase the fee revenues and fees estab-
hshed in subsection (b) if such an adjustment is necessary 
to provide for not more than three months of operating reserves 
of carryover user fees for the process for the review of human 
drug appHcations for the first three months of fiscal year 2008. 
If such an adjustment is necessary, the rationale for the amount 
of the increase shall be contained in the annual notice estab-
lishing fee revenues and fees for fiscal year 2007. If the Sec-
retary has carryover balances for such process in excess of 
three months of such operating reserves, the adjustment under 
this paragraph shall not be made."; and 
(4) in paragraph (4) (as redesignated by paragraph (2) 
of this subsection), by amending such paragraph to read as 
follows: 
"(4) ANNUAL FEE SETTING.—The Secretary shall, 60 days Effective date. 
before the start of each fiscal year that begins after September 
30, 2002, establish, for the next fiscal year, application, product, 
and establishment fees under subsection (a), based on the rev-
enue amounts established under subsection (b) and the adjust-
ments provided under this subsection.". 
(d) FEE WAIVER OR REDUCTION.—Section 736(d)) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (C), by inserting "or" after the 
comma at the end; 
(B) by striking subparagraph (D); and 
(C) by redesignating subparagraph (E) as subpara-
graph (D); and 
(2) in paragraph (3), in each of subparagraphs (A) and 
(B), by striking "paragraph (1)(E)" each place such term appears 
and inserting "paragraph (1)(D)". 
' 
(e) ASSESSMENT OF FEES.—Section 736(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended— 
(1) in the heading for the subsection, by striking "ASSESS-
MENT OF FEES.—" and inserting "LIMITATIONS.—"; and 
(2) in paragraph (1), by striking the heading for the para-
graph and all that follows through "fiscal year beginning" and 
inserting the following: "IN GENERAL.—Fees under subsection 
(a) shall be refunded for a fiscal year beginning". 
(f) CREDITING AND AVAILABILITY OF FEES.— 
(1) IN GENERAL.—Section 736(g)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(g)(l)) is amended 
by striking "Fees collected for a fiscal year" and all that follows 
through "fiscal year limitation." and inserting the following: 
"Fees authorized under subsection (a) shall be collected and 
available for obligation only to the extent and in the amount 
provided in advance in appropriations Acts. Such fees are 
authorized to remain available until expended.". 
(2) 
COLLECTIONS 
AND APPROPRIATION 
ACTS.—Section 
736(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h(g)(2)) is amended— 
(A) by redesignating subparagraphs (A) and (B) as 
clauses (i) and (ii), respectively; 
116 STAT. 692 
PUBLIC LAW 1 0 7 - 1 8 8 - J U N E 12, 2002 
(B) by striking "(2) COLLECTIONS" and all that follows 
through "the amount specified" in clause (i) (as so redesig-
nated) and inserting the following: 
"(2) COLLECTIONS AND APPROPRIATION ACTS.— 
"(A) IN GENERAL.—The fees 
authorized 
by 
this 
section— 
"(i) shall be retained in each fiscal year in an 
amount not to exceed the amount specified"; 
(C) by moving clause (ii) (as so redesignated) two ems 
to the right; and 
(D) by adding at the end the following subparagraph: 
"(B) COMPLIANCE.—The Secretary shall be considered 
to have met the requirements of subparagraph (A)(ii) in 
any fiscal year if the costs funded by appropriations and 
allocated for the process for the review of human drug 
applications— 
"(i) are not more than 3 percent below the level 
specified in subparagraph (A)(ii); or 
"(ii)(I) are more than 3 percent below the level 
specified in subparagraph (A)(ii), and fees assessed 
for the fiscal year following the subsequent fiscal year 
are decreased by the amount in excess of 3 percent 
by which such costs fell below the level specified in 
such subparagraph; and 
"(II) such costs are not more than 5 percent below 
the level specified in such subparagraph.". 
(3) AUTHORIZATION OF APPROPRIATIONS.—Section 736(g)(3) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(g)(3)) is amended by striking subparagraphs (A) through 
(E) and inserting the following: 
"(A) $222,900,000 for fiscal year 2003; 
"(B) $231,000,000 for fiscal year 2004; 
"(C) $252,000,000 for fiscal year 2005; 
"(D) $259,300,000 for fiscal year 2006; and 
"(E) $259,300,000 for fiscal year 2007;". 
Effective dates. 
SEC. 505. ACCOUNTABILITY AND REPORTS. 
2rus^c?79g 
(a) PUBLIC ACCOUNTABILITY.— 
note. 
(1) CONSULTATION.—In developing recommendations to the 
Congress for the goals and plans for meeting the goals for 
the process for the review of human drug applications for 
the fiscal years after fiscal year 2007, and for the reauthoriza-
tion of sections 735 and 736 of the Federal Food, Drug, and 
Cosmetic Act, the Secretary of Health and Human Services 
(referred to in this section as the "Secretary") shall consult 
with the Committee on Energy and Commerce of the House 
of Representatives, the Committee on Health, Education, Labor, 
and Pensions of the Senate, appropriate scientific and academic 
experts, health care professionals, representatives of patient 
and consumer advocacy groups, and the regulated industry. 
Federal Register, 
(2) RECOMMENDATIONS.—The Secretary shall publish in the 
publication. 
Federal Register recommendations under paragraph (1), after 
negotiations with the regulated industry; shall present such 
recommendations to the congressional committees specified in 
such paragraph; shall hold a meeting at which the public may 
present its views on such recommendations; and shall provide 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 693 
for a period of 30 days for the public to provide written com-
ments on such recommendations. 
(b) PERFORMANCE REPORT.—Beginning with fiscal year 2003, 
not later than 60 days after the end of each fiscal year during 
which fees are collected under part 2 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g 
et seq.), the Secretary of Health and Human Services shall prepare 
and submit to the President, the Committee on Energy and Com-
merce of the House of Representatives, and the Committee on 
Health, Education, Labor, and Pensions of the Senate a report 
concerning the progress of the Food and Drug Administration in 
achieving the goals identified in the letters described in section 
502(4) during such fiscal year and the future plans of the Food 
and Drug Administration for meeting the goals. 
(c) FISCAL REPORT.—Beginning with fiscal year 2003, not later 
than 120 days after the end of each fiscal year during which 
fees are collected under the part described in subsection (b), the 
Secretary of Health and Human Services shall prepare and submit 
to the Committee on Energy and Commerce of the House of Rep-
resentatives, and the Committee on Health, Education, Labor, and 
Pensions of the Senate, a report on the implementation of the 
authority for such fees during such fiscal year and the use, by 
the Food and Drug Administration, of the fees collected during 
such fiscal year for which the report is made. 
SEC. 506. REPORTS OF POSTMARKETING STUDIES. 
Section 506B of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356b) is amended by adding at the end the following 
subsections: 
"(d) DISCLOSURE.—If a sponsor fails to complete an agreed 
upon study required by this section by its original or otherwise 
negotiated deadline, the Secretary shall publish a statement on 
the Internet site of the Food and Drug Administration stating 
that the study was not completed and, if the reasons for such 
failure to complete the study were not satisfactory to the Secretary, 
a statement that such reasons were not satisfactory to the Sec-
retary. 
"(e) NOTIFICATION.—^With respect to studies of the type required 
under section 506(b)(2)(A) or under section 314.510 or 601.41 of 
title 21, Code of Federal Regulations, as each of such sections 
was in effect on the day before the effective date of this subsection, 
the Secretary may require that a sponsor who, for reasons not 
satisfactory to the Secretary, fails to complete by its deadline a 
study under any of such sections of such t3T)e for a drug or biological 
product (including such a study conducted after such effective date) 
notify practitioners who prescribe such drug or biological product 
of the failure to complete such study and the questions of clinical 
benefit, and, where appropriate, questions of safety, that remain 
unanswered as a result of the failure to complete such study. 
Nothing in this subsection shall be construed as altering the 
requirements of the types of studies required under section 
506(b)(2)(A) or under section 314.510 or 601.41 of title 21, Code 
of Federal Regulations, as so in effect, or as prohibiting the Sec-
retary from modifying such sections of title 21 of such Code to 
provide for studies in addition to those of such type.". 
116 STAT. 694 
PUBLIC LAW 107-188-^UNE 12, 2002 
21 u s e 379g 
SEC. 507. SAVINGS CLAUSE. 
Notwithstanding section 107 of the Food and Drug Administra-
tion Modernization Act of 1997, and notwithstanding the amend-
ments made by this subtitle, part 2 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act, as in effect 
on the day before the date of the enactment of this Act, continues 
to be in effect with respect to human drug applications and supple-
ments (as defined in such part as of such day) that, on or after 
October 1, 1997, but before October 1, 2002, were accepted by 
the Food and Drug Administration for filing and with respect to 
assessing and collecting any fee required by such Act for a fiscal 
year prior to fiscal year 2003. 
21 u s e 356b 
SEC. 508. EFFECTIVE DATE. 
The amendments made by this subtitle shall take effect October 
1, 2002. 
21 u s e 379g 
SEC. 509. SUNSET CLAUSE. 
The amendments made by sections 503 and 504 cease to be 
effective October 1, 2007, and section 505 ceases to be effective 
120 days after such date. 
Subtitle B—^Funding Provisions Regarding 
Food and Drug Administration 
SEC. 521. OFFICE OF DRUG SAFETY. 
Of the amounts appropriated for the Food and Drug Adminis-
tration for a fiscal year, the Secretary of Health and Human Serv-
ices shall reserve for the Office of Drug Safety (within such Adminis-
tration), the following amounts: 
(1) For fiscal year 2003, an amount equal to the sum 
of $5,000,000 and the amount made available under appropria-
tions Acts for such Office for fiscal year 2002. 
(2) For fiscal year 2004, an amount equal to the sum 
of $10,000,000 and the amount made available under appropria-
tions Acts for such Office for fiscal year 2002. 
(3) For each subsequent fiscal year, an amount equal to 
the sum of the amount made available under appropriations 
Acts for such Office for fiscal year 2004 and an amount suffi-
cient to offset the effects of inflation occurring after the begin-
ning of fiscal year 2004. 
Appropriation 
SEC. 522. DIVISION OF DRUG MARKETING, ADVERTISING, AND COMMU-
authorization. 
NTCATIONS. 
For the Division of Drug Marketing, Advertising, and Commu-
nications (within the Office of Medical Policy, Food and Drug 
Administration), there are authorized to be appropriated the fol-
lowing amounts, stated as increases above the amount made avail-
able under appropriations Acts for such Division for fiscal year 
2002: 
(1) For fiscal year 2003, an increase of $2,500,000. 
(2) For fiscal year 2004, an increase of $4,000,000. 
(3) For fiscal year 2005, an increase of $5,500,000. 
(4) For fiscal year 2006, an increase of $7,500,000. 
(5) For fiscal year 2007, an increase of $7,500,000. 
PUBLIC LAW 107-188-^UNE 12, 2002 
116 STAT. 695 
SEC. 523. OFFICE OF GENERIC DRUGS. 
For the Office of Generic Drugs (within the Food and Drug 
Administration), there are authorized to be appropriated the fol-
lowing amounts, stated as increases above the amount made avail-
able under appropriations Acts for such Ofdce for fiscal year 2002: 
(1) For fiscal year 2003, an increase of $3,000,000. 
(2) For fiscal year 2004, an increase of $6,000,000. 
(3) For fiscal year 2005, an increase of $9,000,000. 
(4) For fiscal year 2006, an increase of $12,000,000. 
(5) For fiscal year 2007, an increase of $15,000,000. 
Appropriation 
authorization. 
Subtitle C—^Additional Provisions 
SEC. 531. TRANSITION TO DIGITAL TELEVISION. 
(a) FAIR ASSIGNMENT REQUIRED.—In order to further promote 
the orderly transition to digital television, and to promote the 
equitable allocation and use of digital channels by television broad-
cast permittees and licensees, the Federal 
Communications 
Commission, at the request of an eligible licensee or permittee, 
shall, within 90 days after the date of enactment of this Act, 
allot, if necessary, and assign a paired digital television channel 
to that licensee or permittee, provided that— 
(1) such channel can be allotted and assigned without 
further modification of the tables of allotments as set forth 
in sections 73.606 and 73.622 of the Commission's regulations 
(47 CFR 73.606, 73.622); and 
(2) such allotment and assignment is otherwise consistent 
with the Commission's rules (47 CFR part 73). 
(b) ELIGIBLE TRANSITION LICENSEE OR PERMITTEE.—For pur-
poses of subsection (a), the term "eligible licensee or permittee" 
means only a full power television broadcast licensee or permittee 
(or its successor in interest) that— 
(1) had an application pending for an analog television 
station construction permit as of October 24, 1991, which 
application was granted after April 3, 1997; and 
(2) as of the date of enactment of this Act, is the permittee 
or licensee of that station. 
(c) REQUIREMENTS ON LICENSEE OR PERMITTEE.— 
(1) CONSTRUCTION DEADLINE.—^Any licensee or permittee 
receiving a paired digital channel pursuant to this section— 
(A) shall be required to construct the digital television 
broadcast facility within 18 months of the date on which 
the Federal Communications Commission issues a construc-
tion permit therefore, and 
(B) shall be prohibited from obtaining or receiving 
an extension of time from the Commission beyond the 
construction deadline established by paragraph (1). 
(2) 
PROHIBITION OF ANALOG OPERATION USING DIGITAL 
PAIR.—^Any licensee or permittee receiving a paired digital 
channel pursuant to this section shall be prohibited from giving 
up its current paired analog assignment and becoming a single-
channel broadcaster and operating in analog on such paired 
digital channel. 
(d) RELIEF RESTRICTED.—^Any paired digital allotment and 
assignment made under this section shall not be available to any 
47 u s e 336 note. 
Deadline. 
116 STAT. 696 
PUBLIC LAW 107-188—JUNE 12, 2002 
Applicability. 
42 use 
1395W-24 note. 
Applicability. 
42 use 
1395W-21 note. 
other applicant unless such applicant is an eligible licensee or 
permittee within the meaning of subsection (b). 
SEC. 
532. 3-YEAR 
DELAY 
IN 
LOCK 
IN 
PROCEDURES FOR 
MEDICARE+CHOICE 
PLANS; 
CHANGE 
IN 
CERTAIN 
MEDICARE+CHOICE DEADLINES AND ANNUAL, COORDI-
NATED ELECTION PERIOD FOR 2003,2004, AND 2005. 
(a) LOCK-IN DELAY.—Section 1851(e) of the Social Security Act 
(42 U.S.C. 1395w-21(e)) is amended— 
(1) in paragraph (2)(A), by striking "THROUGH 2001" and 
"during 1998, 1999, 2000, and 2001" and inserting "THROUGH 
2004" and "during the period beginning January 1, 1998, and 
ending on December 31, 2004", respectively; 
(2) in the heading to paragraph (2)(B), by striking "DURING 
2002" and inserting "DURING 2005"; 
(3) in paragraphs (2)(B)(i) and (2)(C)(i), by striking "2002" 
and inserting "2005" each place it appears; 
(4) in paragraph (2)(D), by striking "2001" and inserting 
"2004"; and 
(5) in paragraph (4), by striking "2002" and inserting "2005" 
each place it appears. 
(b) CHANGE IN REPORTING DEADLINE.— 
(1) I N GENERAL.—Section 1854(a)(1) of such Act (42 U.S.C. 
1395w-24(a)(l)) is amended by striking "Not later than July 
1 of each year" and inserting "Not later than the second Monday 
in September of 2002, 2003, and 2004 (or July 1 of each other 
year)". 
(2) EFFECTIVE DATE.—The amendment made by paragraph 
(1) shall apply to information submitted for years beginning 
with 2003. 
(c) DELAY IN ANNUAL, COORDINATED ELECTION P E R I O D . — 
(1) I N GENERAL.—Section 1851(e) of such Act (42 U.S.C. 
1395w-21(e)) is amended— 
(A) in paragraph (3)(B), by striking "means" and all 
that follows and inserting the following: "means, with 
respect to a year before 2003 and after 2005, the month 
of November before such year and with respect to 2003, 
2004, and 2005, the period beginning on November 15 
and ending on December 31 of the year before such year."; 
and 
(B) in paragraph (6)(A), by striking "each subsequent 
year (as provided in paragraph (3))" and inserting "during 
the annual, coordinated election period under paragraph 
(3) for each subsequent year". 
(2) EFFECTIVE DATE.—The amendment made by paragraph 
(1) shall apply to the annual, coordinated election period for 
years beginning with 2003. 
(d) CHANGE TO ANNUAL ANNOUNCEMENT OF PAYMENT R A T E S . — 
(1) I N GENERAL.—Section 1853(b)(1) of such Act (42 U.S.C. 
1395w-23(b)(l)) is amended by striking "not later than March 
1 before the calendar year concerned" and inserting "for years 
before 2004 and after 2005 not later than March 1 before 
the calendar year concerned and for 2004 and 2005 not later 
than the second Monday in May before the respective calendar 
year". 
PUBLIC LAW 107-188—JUNE 12, 2002 
116 STAT. 697 
(2) EFFECTIVE DATE.—The amendment made by paragraph Applicability. 
shall first apply t 
Approved June 12, 2002. 
(1) shall first apply to announcements for years after 2003. 42 USC 
1395w-23 note. 
LEGISLATIVE HISTORY—H.R. 3448: 
HOUSE REPORTS: No. 107-481 (Comm. of Conference). 
CONGRESSIONAL RECORD: 
Vol. 147 (2001): Dec. 11, 12, considered and passed House. 
Dec. 20, considered and passed Senate, amended. 
Vol. 148 (2002): May 22, House agreed to conference report. 
May 23, Senate agreed to conference report. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002): 
June 12, Presidential remarks.