[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3448 Enrolled Bill (ENR)]
H.R.3448
One Hundred Seventh Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Wednesday,
the twenty-third day of January, two thousand and two
An Act
To improve the ability of the United States to prevent, prepare for, and
respond to bioterrorism and other public health emergencies.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

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(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:

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EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting

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TITLE I

-NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH

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communications abilities of public health agencies.

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Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures

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bioterrorist
attack and other public health emergencies.

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Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies

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and
response to bioterrorism and other public health emergencies.
Subtitle D--Emergency Authorities; Additional Provisions

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defibrillation
demonstration projects.
Subtitle A--Department of Health and Human Services

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TITLE II

-ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS

Subtitle C--Interagency Coordination Regarding Overlap Agents and Toxins

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Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins

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TITLE III

-PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY

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components
intended for use in export products.
Subtitle C--General Provisions Relating to Upgrade of Agricultural
Security

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425183c0c483b4ce91a2c48455a943a3761a0fc3f558598127db6f89853ce16f

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TITLE IV

-DRINKING WATER SECURITY AND SAFETY

Subtitle B--Funding Provisions Regarding Food and Drug Administration

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TITLE V

-ADDITIONAL PROVISIONS

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change in Medicare+Choice reporting deadlines and annual,
coordinated election period for 2003, 2004, and 2005.
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting

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(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 PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC
HEALTH EMERGENCIES
``Subtitle A--National Preparedness and Response Planning,
Coordinating, and Reporting
``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, 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 carrying 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 coordinated
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 furtherance of the following:
``(1) Providing effective assistance to State and local
governments in the event of bioterrorism or other public health
emergency.
``(2) Ensuring that State and local governments have
appropriate capacity to detect and respond effectively to such
emergencies, 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 and safety protection of workers responding to
such an emergency.
``(E) Public health agencies that are prepared to
coordinate 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 entities and to
the public.
``(3) Developing and maintaining 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 of
the enactment of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, and biennially thereafter,
the Secretary shall submit to the Committee on Energy and Commerce
of the House of Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate, a report concerning
progress with respect to the plan under 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) any additional legislative authority that the
Secretary 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
Secretary 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 construed as
expanding or limiting any of the authorities of the Secretary 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.''.
(b) Other Reports.--
(1) In general.--Not later than one year after the date of the
enactment of this Act, the Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary'') shall submit
to the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor, and
Pensions of the Senate, a report concerning--
(A) the recommendations and findings of the National
Advisory Committee on Children and Terrorism under section
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 rural community
uniquely vulnerable to a biological attack, including distance,
lack of emergency transport, hospital or laboratory 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
populations 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 primary 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 determines
is necessary to effectively strengthen rural communities, 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 private-
sector, community-based rapid response corps of medical
volunteers.
(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 Representatives, and the Committee on Health, Education, Labor,
and Pensions of the Senate, a report describing the findings of the
study.

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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
``SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO
BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES.
``(a) Assistant Secretary for Public Health Emergency
Preparedness.--
``(1) In general.--There is established within the Department
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 Preparedness shall
carry out the following duties with respect to bioterrorism 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 activities
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 meeting
the core public health capabilities established pursuant to
319A.
``(D) Any other duties determined appropriate by the
Secretary.
``(b) National Disaster Medical System.--
``(1) In general.--The Secretary shall provide for the
operation in accordance with this section of a system to be known
as the National Disaster 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 Department of Health
and Human Services, the Federal Emergency 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 appropriate
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 Medical
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 Secretary 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 Preparedness 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 otherwise 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 determines to be appropriate.
``(c) Criteria.--
``(1) In general.--The Secretary shall establish criteria for
the operation of the National Disaster Medical System.
``(2) Participation agreements for non-federal entities.--In
carrying out paragraph (1), the Secretary shall establish criteria
regarding the participation of States and private entities in the
National Disaster Medical System, including criteria regarding
agreements for such participation. The criteria shall include the
following:
``(A) Provisions relating to the custody and use of Federal
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 intermittent
personnel of such System in accordance with applicable civil
service laws and regulations.
``(2) Liability.--For purposes of section 224(a) and the
remedies described in such section, an individual appointed under
paragraph (1) shall, while acting within the scope of such
appointment, be considered to be an employee of the Public Health
Service performing medical, surgical, dental, or related functions.
With respect to the participation of individuals appointed under
paragraph (1) in training programs authorized by the Assistant
Secretary for Public Health Emergency Preparedness or a comparable
official of any Federal agency specified in subsection (b)(2)(B),
acts of individuals so appointed that are within the scope of such
participation shall be considered within the scope of the
appointment under paragraph (1) (regardless of whether the
individuals receive compensation for such participation).
``(e) Certain Employment Issues Regarding Intermittent
Appointments.--
``(1) Intermittent disaster-response appointee.--For purposes
of this subsection, the term `intermittent disaster-response
appointee' means an individual appointed by the Secretary 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 participation of individuals
appointed under subsection (d) in training programs authorized by
the Assistant Secretary for Public Health Emergency Preparedness or
a comparable official of any Federal agency specified in subsection
(b)(2)(B), injuries sustained by such an individual, while acting
within the scope of such participation, also shall be deemed `in
the performance of duty' for purposes of chapter 81 of title 5,
United States Code (regardless of whether the individuals receive
compensation for such participation). In the event of an injury to
such an intermittent disaster-response appointee, the Secretary of
Labor shall be responsible for making determinations as to whether
the claimant is entitled to compensation or other benefits in
accordance with chapter 81 of title 5, United States Code.
``(3) Employment and reemployment rights.--
``(A) In general.--Service as an 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 Assistant 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 uniformed services' for purposes of
chapter 43 of title 38, United States Code, pertaining to
employment and reemployment rights of individuals who have
performed service in the uniformed services (regardless of
whether the individual receives compensation for such
participation). All rights and obligations of such persons and
procedures for assistance, enforcement, and investigation shall
be as provided for in chapter 43 of title 38, United States
Code.
``(B) Notice of absence from position of employment.--
Preclusion of giving notice of service by necessity of Service
as an 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 Secretary 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 Regular 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
`auxiliary services' includes mortuary services, veterinary services,
and other services that are determined by the Secretary to be
appropriate with respect to the needs referred to in subsection
(b)(3)(A).
``(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
System, other than purposes for which amounts in the Public Health
Emergency Fund under section 319 are available, there are authorized to
be appropriated such sums as may be necessary for each of the fiscal
years 2002 through 2006.''.
(b) Sense of Congress Regarding Resources of National Disaster
Medical System.--It is the sense of the Congress that the Secretary of
Health and Human Services should provide sufficient 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 Medical System.

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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 modern
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 Disease
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 any 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 disease
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 preceding sentence include--
``(A) expanding or enhancing the training of personnel;
``(B) improving communications facilities and networks,
including delivery of necessary information to rural areas;
``(C) improving capabilities for public health surveillance
and reporting activities, taking into account the integrated
system or systems of public health alert communications and
surveillance networks under subsection (b); and
``(D) improving laboratory facilities related to
bioterrorism and other public health emergencies, including
increasing the security of such facilities.
``(b) National Communications and Surveillance Networks.--
``(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 systems 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,
hospitals, and other health care facilities; and
``(C) any other entities determined appropriate by the
Secretary.
``(2) Requirements.--The Secretary shall ensure that networks
under paragraph (1) allow for the timely sharing and discussion, in
a secure manner, of essential information concerning bioterrorism
or another public health emergency, or recommended methods for
responding to such an attack or emergency.
``(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 interoperability) for
networks under paragraph (1).
``(c) Authorization of Appropriations.--
``(1) Facilities; capacities.--
``(A) Facilities.--For the purpose of carrying out
subsection (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 purposes 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 appropriated such sums
as may be necessary for each of the fiscal years 2002 through
2006.
``(2) National communications and surveillance networks.--For
the purpose of carrying out subsection (b), there are authorized to
be appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2006.''.

1243c54adf65dd3637153fd1c3242ecea58b68250684fce5e631153ef56e73ae

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 subsections
(e) through (j), respectively; and
(3) by inserting after subsection (a) the following
subsections:
``(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 paragraphs (2) and (3) to
provide expert recommendations to assist such working groups in
carrying out their respective responsibilities under subsections
(a) and (b).
``(2) National advisory committee on children and terrorism.--
``(A) In general.--For purposes of 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 emergency
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 relevant
professional disciplines.
``(D) Termination.--The Advisory Committee terminates 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 communications advisory
committee.--
``(A) In general.--For purposes of paragraph (1), the
Secretary shall establish an advisory committee to be known as
the Emergency Public Information and Communications Advisory
Committee (referred to in this paragraph 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 to communicate
public health information regarding bioterrorism 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, communications, 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 Communication of Information Regarding
Bioterrorism and Other Public Health Emergencies.--In coordination with
working group under subsection (a), the Secretary shall develop a
strategy for effectively communicating 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 sentence directly or through grants, contracts, or
cooperative agreements.
``(d) Recommendation of Congress Regarding Official Federal
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 relevant to diverse
populations (including messages directed at the general public and such
relevant groups as medical personnel, public safety workers, and
agricultural workers) and links to appropriate 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 determine
whether local public health entities have the ability to maintain
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 recommendations to industry and public health entities
about how to implement such redundancies if necessary.

7c5522f92fe160aed9aaffad75191f8b23a9b6fa22d88a3d54481d55fe949d1d

PEDIATRIC ISSUES.
Section 319F(g) of the Public Health Service Act, as redesignated
by section 104(a)(2) of this Act, is amended to read as follows:
``(g) Education; Training Regarding Pediatric Issues.--
``(1) Materials; core curriculum.--The Secretary, in
collaboration with members of the working group described in
subsection (b), and 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 children 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
laboratory 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 education
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 accrediting 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 interagency cooperative
agreements with other Federal agencies.
``(4) Health-related assistance for emergency response
personnel training.--The Secretary, in consultation with the
Attorney General and the Director of the Federal Emergency
Management Agency, may provide technical assistance with respect to
health-related aspects of emergency response personnel training
carried out by the Department of Justice and the Federal Emergency
Management Agency.''.

a345667bad901ad216c44e18b42a92b9535cda07867a775cc0ee78829e93280c

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 CERTAIN HEALTH
PROFESSIONALS.
``(a) In General.--The Secretary may make awards of grants and
cooperative agreements to appropriate public and nonprofit 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 fellowships,
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 subsection (a) that a
grantee under such subsection provide non-Federal contributions toward
the purpose described in such subsection.
``(c) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2002 through 2006.''.

2b417948f535cfc8ffd618f32dcb87abed7e996c38690902a75bbefd9cd880c4

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:
``SEC. 319I. 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 professionals
for the purpose of verifying the credentials, licenses, accreditations,
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 Criteria.--The Secretary shall establish provisions
regarding the promptness and efficiency of the system in collecting,
storing, updating, and disseminating information on the credentials,
licenses, accreditations, and hospital privileges of volunteers
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 construed 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.''.

be6205ada6fb7b9f9c1fb0687a15987995800c918570ec33cddba47d7c8ca683

Section 319F of the Public Health Service Act, as amended by
section 104(a), is amended by striking subsection (a) and 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 subcommittees thereof, shall meet
periodically for the purpose of consultation 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 351A;
``(C) facilitation of the awarding of grants, contracts, or
cooperative agreements for the development, manufacture,
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 and 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 security officers, or other emergency response
personnel (including private response contractors); and
``(ii) hospitals, primary care facilities, and public
health agencies;
``(H) development of strategies for Federal, State, and
local agencies to communicate information to the public
regarding biological threats or attacks;
``(I) ensuring that the activities under this subsection
address the health security needs of children and other
vulnerable populations;
``(J) strategies for decontaminating facilities
contaminated as a result of a biological attack, including
appropriate 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 subparagraphs
(B) and (C) of paragraph (1), the working group under such
paragraph shall consult with the pharmaceutical, biotechnology, and
medical device industries, and other appropriate experts.
``(3) Use 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 subcommittee 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 committed 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 responsibilities and
authorities of the Environmental Protection Agency.''.

9fee85352634c5893cf6a3a15242f5dab38c2d7d5fd605295178d0494a80f143

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 determined by
the Director of the National Institutes of Health in consultation
with the task force established 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 (e)(2), 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.''.

63da60bf322c422a8d4fb45cc08b1cc3bbbd1b99c488b7d22c579bf9e4fae369

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 319I the
following section:
``SEC. 319J. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.
``(a) In General.--Upon the request of a recipient of an award
under any of sections 319 through 319I or section 319K, the Secretary
may, subject to subsection (b), provide supplies, equipment, and
services for the purpose of aiding the recipient in carrying out the
purposes for which the award is made and, for such purposes, may detail
to the recipient any officer or employee of the 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 and the fair market value of any supplies,
equipment, or services provided by the Secretary. The Secretary shall,
for the payment of expenses incurred in complying with such request,
expend the amounts withheld.''.

0a497a40158c5deefc12945444a6883f991fee9c8850007e8361b09fcbfaa0af

Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended--
(1) in section 319A(a)(1), by striking ``10 years'' and
inserting ``five years'';
(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: ``,
professional organization or society, school or program that
trains medical laboratory personnel, private accrediting
organization, or other nonprofit private institution or entity
meeting criteria established by the Secretary''.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures

989cfb19f32f421d016e93dbded9f9d77f0ab59bf9262b63773b09be2c0edd3d

(a) Strategic National Stockpile.--
(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 maintain a stockpile
or stockpiles of drugs, vaccines and other biological products,
medical devices, and other supplies in such numbers, types, and
amounts as are determined by the Secretary to be 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 under
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
officials, 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 stockpile.
(b) Smallpox Vaccine Development.--
(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 section
552, United States Code, any information identifying the location 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 under which such vendor or vendors agree to provide to
the Secretary supplies described in subsection (a).
(e) Authorization of Appropriations.--
(1) Strategic national stockpile.--For the purpose of carrying
out subsection (a), there are authorized to be appropriated
$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 appropriated
$509,000,000 for fiscal year 2002, and such sums as may be
necessary for each of fiscal years 2003 through 2006.

d301574e72ac126422c942acbc9ce4bc762080742adfb1dbe69feaef08b3c579

(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 be made prior
to the submission of--
(1) a request for designation by the sponsor or applicant; or
(2) an application for the investigation of the drug under
section 505(i) of such Act or section 351(a)(3) of the Public
Health Service Act.
Nothing in this subsection shall be construed to prohibit a sponsor or
applicant from declining such a designation.
(b) Use of Animal Trials.--A drug for which 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
biologics application referred to in section 101(4) of the Food and
Drug Administration Modernization Act of 1997.

a4707dd9144fd59fbe7499ff36aed5e37f62c8bb146fd2ea04161b7cafe8fb43

Not later than 90 days after the date of the enactment of 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 Products; 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.

0fed0d8e00a665748d0c93ca5c7a04ebbc1d5f9eb1b04f861ba3f7174957df38

Part B of title III of the Public Health Service Act, as amended by
section 110 of this Act, is amended by inserting after section 319J the
following section:
``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 technical 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.''.

a86b9d19803f1ea2214c6d7cee0f36fa967f65c733deffae59b022237260d160

Section 319F(h) of the Public Health Service Act, as redesignated
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 Secretary, taking into consideration any
recommendations of the working group under subsection (a), shall
conduct, and award grants, contracts, or cooperative agreements
for, research, investigations, experiments, demonstrations, and
studies in the health sciences relating to--
``(A) the epidemiology and pathogenesis of such pathogens;
``(B) the sequencing of the genomes, or other DNA analysis,
or other comparative analysis, of priority pathogens (as
determined by the Director of the National Institutes of Health
in consultation with the working group established in
subsection (a)), in collaboration and coordination with the
activities of the Department of Defense and the Joint Genome
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 and other
vulnerable populations.
``(2) Priority.--The Secretary shall 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 carrying out
paragraph (1), the Secretary shall consider using the biomedical
research and development capabilities of the Department of Veterans
Affairs, 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.
``(4) Priority countermeasures.--For purposes of this section,
the term `priority countermeasure' means a drug, biological
product, device, vaccine, vaccine adjuvant, antiviral, or
diagnostic 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)(1), 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 subparagraph (A).''.

89768470c40e1eace0e09db6ae4e95bc27a5dbc3c0ac12719c4391d422f94c0e

BIOTERRORIST ATTACK AND OTHER PUBLIC HEALTH EMERGENCIES.
(a) In General.--The Secretary 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 technologies
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 bioterrorist 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 Federal
Government for potentially useful technologies;
(2) promptly issue a request, as necessary, for information
from non-Federal public and private entities for ongoing activities
in this area; and
(3) evaluate technologies identified under paragraphs (1) and
(2) pursuant to subsection (c).
(c) Consultation and Evaluation.--In carrying out subsection
(b)(3), the Secretary shall consult with the working group under
section 319F(a) of the Public Health Service Act, as well as other
appropriate public, nonprofit, and private entities, to develop
criteria for the evaluation of such technologies and to conduct such
evaluations.
(d) Report.--Not later than 180 days after the date of the
enactment of this Act, and periodically thereafter, the Secretary shall
submit to the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor, and
Pensions of the Senate, a report on the activities under this section.

137b8c5694f510519ae1a1f6150075ba9f7a967c67ea78fb4fc25eaba65d1fc7

(a) In General.--Through the national stockpile under section 121,
the President, subject to subsections (b) and (c), shall make available
to State and local governments potassium iodide tablets for stockpiling
and for distribution as appropriate to public facilities, such as
schools and hospitals, 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:
(A) Such government submits to the President a plan for the
stockpiling 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 conditions 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 (1)(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 inconsistent 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 agencies, 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 guidelines 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 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
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 alternative
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

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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 partially, any sanctions otherwise applicable to such
failure to comply. Before or promptly after granting such an extension
or waiver, the Secretary shall notify the Congress of such action and
publish in the Federal Register a notice of the extension or waiver.''.

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PROVISIONS.
(a) Elimination of Prerequisite for National Advisory Health
Council Recommendation Before Issuing Quarantine Rules.--
(1) Executive orders specifying diseases subject to individual
detentions.--Section 361(b) of the Public Health Act (42 U.S.C.
264(b)) is amended by striking ``Executive orders of the President
upon the recommendation of the National Advisory Health Council and
the Surgeon General'' and inserting ``Executive orders of the
President upon the recommendation of the Secretary, in consultation
with the Surgeon General,''.
(2) Regulations providing for apprehension of individuals.--
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 individuals 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 inserting ``the Secretary,
in consultation with the Surgeon General,''.
(b) Apprehension Authority To Apply in Cases of Exposure to
Disease.--
(1) Regulations providing for apprehension of individuals.--
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 individuals in
wartime.--Section 363 of the Public Health Act (42 U.S.C. 266), as
amended by subsection (a)(3), is further amended by 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.''.

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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 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
available to meet the needs of individuals in such area enrolled in
the programs under titles XVIII, 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 noncompliance, absent any
determination of fraud or abuse.
``(b) Secretarial Authority.--To the extent necessary to accomplish
the purpose specified in subsection (a), the Secretary is authorized,
subject to the provisions of this section, to temporarily waive or
modify the application 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 thereunder (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 1851(i) for health
care items and services furnished to individuals enrolled in a
Medicare+Choice plan by health care professionals or facilities 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 part C of title XVIII.
``(c) Authority for Retroactive Waiver.--A waiver or modification
of requirements pursuant to this section may, at the Secretary'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--
``(A) the specific provisions that will be waived or
modified;
``(B) the health care providers to whom the waiver or
modification will apply;
``(C) the geographic area in which the waiver or
modification will apply; and
``(D) the period of time for which the waiver or
modification will be in effect; and
``(2) a certification that the waiver or modification is
necessary 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 Secretary
pursuant to section 319 of the Public Health Service Act.
``(2) Health care provider.--The term `health care provider'
means any entity that furnishes health care items or services, and
includes a hospital or other provider of services, a 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) shall be
effective on and after September 11, 2001.

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(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 emergency 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 terminate 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

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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.''.

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(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 identification 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.
(3) Report.--Not later than 180 days after the date of 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 section,
there are authorized to be appropriated such sums as may be necessary
in each of fiscal years 2002 through 2006.

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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.

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VETERANS AFFAIRS.
(a) Readiness of Department Medical Center.--(1) The Secretary 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 personal
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 Facilities.--(1)
Not later than 180 days after the date of the enactment of this Act,
the Secretary shall carry out an evaluation of the security needs at
Department medical centers and research facilities. 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
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 centralized
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 recommendations 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 following:
(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 providers 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.

08b22add2ab9364556e4cb3ca0b4b434480ed2e1152ea70cdc23091c9470e659

Section 582(f) of the Public Health Service Act (42 U.S.C. 290hh-
1(f)) is amended by striking ``2002 and 2003'' and inserting ``2003
through 2006''.

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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 mission
of, established university programs would be one appropriate 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 Secretary makes
awards of grants and contracts in accordance with this Act and the
amendments made by this Act.

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(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 Committee on Energy and
Commerce and the Committee on Appropriations 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.

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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''.

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DEFIBRILLATION DEMONSTRATION PROJECTS.
(a) Short Title.--This section may be cited as the ``Community
Access to Emergency Defibrillation Act of 2002''.
(b) 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 ventricular
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:
``SEC. 312. PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
``(a) In General.--The Secretary shall award grants to States,
political subdivisions of States, Indian tribes, and tribal
organizations to develop and implement public access defibrillation
programs--
``(1) by training and equipping local emergency medical
services personnel, including firefighters, police officers,
paramedics, 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 manufacturers
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 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 commitment
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 automated
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 reasonably
require.
``(2) Contents.--An application submitted under paragraph (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 the local
emergency medical services system in the oversight 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 and 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.
``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
settings;
``(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 automated
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.
``(2) Contents.--An application submitted under paragraph (1)
may--
``(A) describe the innovative, comprehensive, community-
based public access defibrillation demonstration project to be
funded with the grant;
``(B) explain how such public access defibrillation
demonstration 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 resuscitation
and automated external defibrillation to cardiac arrest
victims in the setting served by the demonstration 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.''.
Subtitle A--Department of Health and Human Services

caf73399cb0321c333ef0af1938565c84ab27ff87f5437f3943e322a8bcf0c5e

3d08822014dca159d777d867e0902492082c0a27cece77716d52ed3cc3a1a1fa

(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 351A 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 351A 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 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 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)(1) of the Public Health
Service Act and that were underway as of the effective date of such
rule.

0e4d6e7dc38c6300231a63646b95849da2942c75aa5a5562cdfab234af2c3008

(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 351A 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 accordance with such section 351A and with section 202
of this Act.
(b) Effective Date Regarding Disclosure of Information.--Subsection
(h) of section 351A 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.

fcf5a9400efd0ce432e36e907cedd1d1e090fdffd89e0efae06b2a30ef5799cf

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

b0ba8abd11e9cb1ee165bc8809b754bedeadb6042a06aa79a99c8116781be16a

This subtitle may be cited as the ``Agricultural Bioterrorism
Protection Act of 2002''.

4644592d776bdf2dedcaa594fb889d89a9124b7208238f783473f59c3390fa32

89468ffdc3aee4d5487a07601c5b3bd41eb76c15d9b6b57852f3f0b6b4f110e4

(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
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.
Subtitle C--Interagency Coordination Regarding Overlap Agents and
Toxins

1b9e6c69a98d07972092368c50d47df65ccf5dae7ac3f6cc035b4db4a895382c

(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 purposes of
this section:
(A) The term ``overlap agent or toxin'' means a biological
agent or toxin that--
(i) is listed pursuant to section 315A(a)(1) of the
Public Health Service Act, as added by section 201 of this
Act; and
(ii) is listed pursuant to section 212(a)(1) of this
Act.
(B) The term ``section 351A program'' means the program
under section 351A of the Public Health Service Act.
(C) The term ``section 212 program'' means the program
under section 212 of this Act.
(b) Certain Matters.--In carrying out the section 351A program and
the section 212 program, the Secretary of Health and Human Services and
the Secretary of Agriculture shall, to the greatest extent practicable,
coordinate activities to achieve the following 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 subject 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 351A and section 212 programs is
contained in both the national database under the section 351A
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 understanding
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 paragraph (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 351A 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 administering the
section 351A 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--
(i) the agency receiving the single registration form
under one of such programs informs the agency administering
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 351A program and the section 212
program for names and other identifying 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 General) a submission, at the
option of the person, to either the agency administering the
section 351A 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 subparagraph (A).
(C) A procedure through which the agencies administering
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 351A 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 memorandum of
understanding under paragraph (1) shall be implemented not later
than 180 days after the date of the enactment of this Act. Until
the single system of registration under paragraph (2) is
implemented, persons who possess, use, or transfer overlap agents
or toxins shall register under both the section 351A program and
the section 212 program.
(d) Joint Regulations.--Not later than 18 months after the 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.
Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins

ccb1eb0fb78cd3a810f8d7125e8d778db8fb4d2aeca23e714f2f8bda03fb82eb

(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 placement
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 351A 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.--Whoever
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.--Whoever
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 registration 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
(B) in the heading for the section, by striking
``Possession 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--
(A) in subsection (a)(1), by striking ``described in
subsection (b)'' and all that follows and inserting the
following: ``shall ship or transport in or affecting interstate
or foreign commerce, or possess in or affecting interstate or
foreign commerce, any biological agent or toxin, or receive any
biological agent or toxin that has been shipped or transported
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 351A
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 synthesized component 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
infectious substances, or a recombinant or synthesized
molecule, whatever their origin and method of production, and
includes--''; and
(C) in paragraph (4), by striking ``recombinant molecule,''
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
(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)''.
Subtitle A--Protection of Food Supply

a672468c91d0960ea5eb14487673ca55978b16cacdf893d56b2c6bdaa8cf4ff5

(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 transportation; response and
notification procedures; and risk communications 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.

35b4d5865876a2d321f9679fa2ef5a6adb7b0ffbc838a050e3969217d3cc338f

(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 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)(1) 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 Protection Agency,
and the Secretary of Agriculture.
``(4) The Secretary shall annually submit to the Committee on
Energy and Commerce of the House of Representatives, and the Committee
on Health, Education, Labor, and Pensions of the Senate, a report
describing the progress made in research under paragraph (1), including
progress regarding paragraph (2).''.
(e) Assessment of Threat of Intentional Adulteration of Food.--The
Secretary of Health and Human Services, acting through the Commissioner
of Food and Drugs, shall ensure that, not later than six months after
the date of the enactment of this Act--
(1) the assessment that (as of such date of 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
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.

0205ab7cc972d4597843e673749a9b49248a25614518714285201aae22b8d54c

(a) Expanded Authority.--Section 304 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 334) is amended by adding at the end the
following subsection:
``(h) Administrative Detention of Foods.--
``(1) Detention authority.--
``(A) In general.--An officer or qualified employee of the
Food and Drug Administration may order the detention, in
accordance with this subsection, of any article of food that is
found during an inspection, examination, or investigation under
this Act conducted by such officer or qualified employee, if
the officer or qualified employee has credible 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 action under subsection (a) or

359d7f6ef6ccca3cce27e8150074408e8cd3c9fa07dfa8c36a91bd9132f0b405

procedures for instituting such action on an expedited basis with
respect to perishable foods.
``(3) Security of detained article.--An order under paragraph
(1) with respect to an article of food may require that such
article be labeled or marked as detained, and 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 construed 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 opportunity, 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:
``(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:
``(j)(1) If an officer or qualified employee of the Food and Drug
Administration has credible evidence or information indicating that an
article of food presents a threat of serious adverse health
consequences or death to humans or animals, and such officer or
qualified employee is 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 qualified 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 article 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 under this Act in which the article
involved is located, or is an official senior to such director.
``(4) With respect to an article of food for which a request under
paragraph (1) is made, the Secretary, promptly after the request is
made, shall notify the State in which the port of entry involved is
located that the request has been made, and as applicable, that such
article is being held under this subsection.''.

467a5597b57814218a345f12a9453baf164fa61d79db15d34405fa4e6528a7c4

(a) Debarment Authority.--
(1) Permissive debarment.--Section 306(b)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is amended--
(A) 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 subparagraph
(A), by inserting ``subparagraph (A) or (B) of'' before
``paragraph (1)'';
(B) by redesignating paragraph (3) as paragraph (4); and
(C) by inserting after paragraph (2) the following
paragraph:
``(3) Persons subject to permissive debarment; food
importation.--A person is subject to debarment under paragraph
(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(l)(2) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a(l)(2)) is amended--
(1) in the first sentence--
(A) by striking ``and'' after ``subsection (b)(2),''; and
(B) by inserting ``, and subsection (b)(3)(A)'' after
``subsection (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).''.
(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 subsection:
``(k)(1) 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 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.
``(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 person,
that the article complies with the requirements of this Act, as
determined by the Secretary.''.

62a8e53d8d2efc38dd16d9af377ca00b574321063740ce7b6dbfc3d1ca1709e5

(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the
following:
``SEC. 415. REGISTRATION OF FOOD FACILITIES.
``(a) Registration.--
``(1) In general.--The Secretary shall by regulation require
that any facility engaged in manufacturing, processing, packing, or
holding food for consumption in the United States be registered
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 conducts business and,
when determined necessary by the Secretary through guidance, the
general food category (as identified under section 170.3 of title
21, Code of Federal Regulations) of any food manufactured,
processed, packed, or held at such facility. The registrant shall
notify the Secretary in a timely manner of changes to such
information.
``(3) Procedure.--Upon receipt of a completed registration
described in paragraph (1), the Secretary shall notify the
registrant of the receipt of such registration and assign a
registration number to each registered facility.
``(4) List.--The Secretary shall compile and maintain an up-to-
date list of facilities that are registered under this section.
Such list and any registration documents submitted pursuant to this
subsection shall not be subject to disclosure under section 552 of
title 5, United States Code. Information derived from such list or
registration documents shall not be subject to disclosure 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 establishment 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 Regulations).
``(2) The term `domestic facility' means a facility located in
any of the States or Territories.
``(3)(A) The term `foreign facility' means 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 Secretary to require an application, review,
or licensing process.''.
(b) Prohibited 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 amended by section 304(e) of this Act,
is amended by adding at the end the following subsection:
``(l)(1) If an article 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 article, 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 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.''.
(d) Electronic Filing.--For the purpose of reducing paperwork 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 pursuant to this section. In
providing for the electronic submission of such registrations, the
Secretary shall ensure adequate authentication 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 after the
date of the enactment of this Act, the Secretary of Health and Human
Services shall promulgate proposed and final regulations 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 expiration of
such period, subject to compliance with the final regulations when
the final regulations are made effective.

c23f1639a0d8c259ff5b6a02ed2c111bee89951ff073a3d97ac5b8204f641f6d

(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.
``(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 manufactures, 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
to all records relating to the manufacture, processing, packing,
distribution, receipt, holding, or importation of such article
maintained by or on behalf of such person in any format (including
paper and electronic formats) and at any location.
``(b) Regulations Concerning Recordkeeping.--The Secretary, in
consultation and coordination, as appropriate, with other Federal
departments and agencies with responsibilities for regulating 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.
``(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, processes, 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 sentence''.
(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 requirements under
subsection 414(b) of the Federal Food, Drug, and Cosmetic Act (as added
by subsection (a)).

2f294bfc30cf826fc1235599393b0a41750f027716e9d5a7c22ad2d9795296c1

(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)(1) In the case of an article of food that is being imported
or offered for import into the United States, the Secretary, after
consultation with the Secretary of the Treasury, shall by regulation
require, for the purpose of enabling such article to be inspected at
ports of entry into the United States, the submission to the Secretary
of a notice providing the identity of each of the following: The
article; the manufacturer and shipper of the article; if known within
the specified period of time that notice is required to be provided,
the grower of the article; the country from which the article
originates; the country from which the article is shipped; and the
anticipated port of entry for the article. An article of food imported
or 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 determines 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 possession
of the Secretary any credible evidence or information indicating that
such article presents a threat of serious adverse health consequences
or death to humans or animals.
``(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 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),
or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 305(b) of this Act, is amended by
adding at the end the following:
``(ee) The importing or offering for import into the United States
of an article of food in violation of the requirements under section
801(m).''.
(c) Rulemaking; Effective Date.--
(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 final regulations 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 requirement 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
takes 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 shall be not fewer than eight hours and not
more than five days, which shall remain in effect until the final
regulations are made effective.

193b3567db4f36d3457f0ea7db3d1316295393cd0c6cbe363ca3a8bf6597f2db

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)(1) 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 ENTRY'.
``(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, shall constitute a lien
against future importations made by such owner or consignee.
``(3) A requirement under paragraph (1) remains in effect until the
Secretary determines that the food involved has been brought into
compliance with this Act.''.
(b) Misbranded Foods.--Section 403 of the 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)(1) (relating to food refused admission into the
United States);
``(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 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.

de2e5f12304018eec4b945e6e4c36d5c589ac022be53e44ba3b86431095c4c5b

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 Secretary.''.

e37add6387d2e123b88f0f2f2ced1e299bc28e2d113f2582ab89fec55b42fa70

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.
``(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 construed as
limiting the authority of the Secretary with respect to food under any
other provision of this Act.''.

911e868d3305c1c36e91daf2f12f8f7fcaa6d20e0b0d0bd8a11e212e38dd7b92

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.
``(a) In General.--The Secretary is authorized to make grants 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 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 public
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.''.

883e7c184932bb1863e37f893656e2e4f801bcb382772393da231c8a1bc513c5

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:
``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 establishing 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.''.

ff107600e20a465afb0771dbe24aaee456b603036e662057a3f03d8efdde9b31

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.

235865ed2218a292fd25fb8260f297fa02025e3d55836b5f1dfabc8db6bdd5a6

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
paragraph (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 and investigations. The memorandum of
understanding shall contain 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 and another Federal department or agency is effective
only in the case of examinations or inspections at facilities 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 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 department 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 memorandum;
``(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 investigations
that were carried out pursuant to such memorandum.''.

54b4a4aba747920efe0bf00868d32962a96baeb4e4365ab37d698f411c4b77c2

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

18c81db46fc2937ef18f435d8d313f299c7312fa61cba040d4d6e4e366b4a2b6

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)(1)--
(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)(1), in the first sentence, by striking
``or (d)'' and inserting ``(d), or (i)''.
(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 consignee 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 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.''.
(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:
``(ff) The importing or offering for import into the United States
of a drug or device with respect to which there is a failure to comply
with a request of the Secretary to submit to the Secretary a statement
under section 801(o).''.
(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.

11451a1cb6f4b41554e792f96886d416dba01a5a81a42469d31be778ab69ccec

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 following:
``(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, 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.
``(III) 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 maintains records on the
use or destruction of such article or portions thereof, as the case
may be, and submits to the Secretary any such records requested by
the Secretary.
``(v) Upon request of the Secretary, the initial owner or
consignee submits a report that provides an accounting of the
exportation or destruction of such article or portions thereof, and
the manner in which such owner or consignee complied with the
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 accordance 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
responsibility 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 statement,
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 accordance with section 801(e)
or 802, or with section 351(h) of the Public Health Service Act; or the
failure to so export or to destroy such an article or portions thereof,
or such a finished product.''.
(c) Effective Date.--The amendments made by this section take
effect upon the expiration of the 90-day period beginning on the date
of the enactment of this Act.
Subtitle C--General Provisions Relating to Upgrade of Agricultural
Security

2172cf608acf06f3de5023e501aef1a556d2545c0535afcda63211108de248c9

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
international points of origin;
(2) improve surveillance at ports of entry and customs;
(3) enhance methods of protecting against the introduction of
plant and animal disease organisms by terrorists;
(4) develop new and improve existing strategies and
technologies for dealing with intentional outbreaks of plant and
animal disease arising from acts of terrorism or from unintentional
introduction, including--
(A) establishing cooperative agreements among Veterinary
Services of the Animal and Plant Health Inspection Service,
State animal health commissions and regulatory agencies for
livestock and poultry health, and private veterinary
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 Secretary 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.

f1f8cb9c342d3b1b93beaa0482d87f0f8e2f1502b5547873776436d96b331f6f

(a) In General.--The Secretary of Agriculture may utilize existing
authorities to give high priority to enhancing 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 and wholesomeness of meat and poultry products;
(2) improve the capacity of the Service to inspect
international meat and meat products, poultry and poultry products,
and egg products at points of origin and at ports of entry;
(3) strengthen the ability of the Service to collaborate with
relevant agencies within the Department of Agriculture and with
other entities in the Federal Government, 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))) 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.

82662cf300f0070615999b80bfe0a5efca7b63054b33b635e7115c5e593e7666

There is authorized to be appropriated for fiscal year 2002,
$180,000,000 for the purpose of enabling the Agricultural 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 Biosafety 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 allocated for the
Agricultural Research Service/Animal and Plant Health Inspection
Service facility in Ames, Iowa. There are authorized 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 biocontainment laboratory
for poultry research in Athens, Georgia, and for the planning,
updating, and renovation of the Arthropod-Borne Animal Disease
Laboratory in Laramie, Wyoming.

d3dc10531d81c6bf158f4568210356ce35e2cf9c9991a16dd3b9cd3c536c21c2

(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 subsection
are colleges or universities that--
(A) are colleges or universities as defined in section 1404
of the National Agricultural Research, Extension, and Teaching
Policy Act of 1977 (7 U.S.C. 3103); and
(B) have programs in food and agricultural sciences, as
defined in such section.
(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 programs 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 consortium 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 Appropriations.--There are authorized to be
appropriated to carry out this section such sums as may be necessary
for each fiscal year.

d99cf47bdb3c86bc258609061f50563dc06fa830ec96b0ea9e2353944275ea12

(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 development,
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 analyses, incident
response, detection, and prevention technologies;
(3) strengthen coordination with the intelligence community 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 international
organizations dealing with plant and animal disease control;
(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 protect
against the threat of bioterrorism.
(b) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $190,000,000 for fiscal year
2002, and such sums as may be necessary for each subsequent fiscal
year.

745ce968b4d41c3f6a798900801d983a7bcc2393dbee8c798bd75e8070922b91

(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 property
(including animals or records) used by the animal enterprise, 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.''.

72c45c3e28a251d95310a0594b8893f72d1726e328601a4b13406120da3dd105

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 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. The
vulnerability assessment shall include, but not be limited to, a review
of pipes and constructed conveyances, physical barriers, water
collection, pretreatment, treatment, storage and distribution
facilities, electronic, computer or other automated systems which are
utilized by the public water system, the use, storage, or handling of
various chemicals, and the operation and maintenance of such system.
The Administrator, not later than 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
provide a safe and reliable supply of drinking water; or
``(B) otherwise present significant public health concerns.
``(2) Each community water system referred to in paragraph (1)
shall certify to the Administrator that the system has conducted an
assessment complying with paragraph (1) and shall submit to the
Administrator a written copy of the assessment. Such certification 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
population 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 intelligence
officials, shall develop such protocols as may be necessary to protect
the copies of the assessments required to be submitted 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 submitted
under paragraph (2), or any reproduction of such assessment, or any
information derived from such assessment, and who knowingly 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 submitted 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 subcommittee 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 incorporates the results of
vulnerability assessments that have been completed. Each such community
water system shall certify to the Administrator, as soon as reasonably
possible after the enactment of this section, but not later than 6
months after the completion of the vulnerability assessment under
subsection (a), that the system has completed such plan. The emergency
response plan shall include, but not be limited to, plans, procedures,
and identification 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 shall, to the extent possible, coordinate with existing Local
Emergency Planning Committees established under the Emergency Planning
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 significantly affect the public health or
significantly affect the safety or supply of drinking water provided to
communities and individuals.
``(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 importance and significant
threats to public health and the supply of drinking water as determined
by a vulnerability assessment conducted 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 detection
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 automated
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 various
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 alleviating 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 sources of water for
such systems) which the Administrator determines 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).

6fccfd4e0c326633b275850a0df54c2cf683f95ab52e050642d773664cb25521

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.
``(a) In General.--The Administrator, in consultation with the
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 technologies 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).
``SEC. 1435. SUPPLY DISRUPTION PREVENTION, DETECTION AND RESPONSE.
``(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 distribution
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 constructed
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 provide
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 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.''.

fc3adfcf5e672185f0a391434b6c0e6a978e228b99ab73b90f3512ff8aef9007

The Safe Drinking Water Act is amended as follows:
(1) Section 1414(i)(1) is amended by inserting ``1433'' after
``1417''.
(2) Section 1431 is amended by inserting in the first sentence
after ``drinking water'' the following: ``, or that there is a
threatened or potential terrorist attack (or other intentional act
designed to disrupt the provision of safe drinking water or to
impact 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
subsection (b) not more than $35,000,000 for the fiscal year 2002 and
such sums as may be necessary for each fiscal year thereafter.''.
Subtitle A--Prescription Drug User Fees

5abd3845982f74885722712c04258809f883f96333c8bc5fff00efdb751d2f37

This subtitle may be cited as the ``Prescription Drug User Fee
Amendments of 2002''.

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Biological Chemical Attack bill — HR. 3448

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