Congressional Record: December 11, 2001 (House)
Page H9195-H9217
PUBLIC HEALTH SECURITY AND BIOTERRORISM RESPONSE ACT OF 2001
Mr. TAUZIN. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 3448) to improve the ability of the United States to
prevent, prepare for, and respond to bioterrorism and other public
health emergencies
The Clerk read as follows:
H.R. 3448
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION. 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the "Public
Health Security and Bioterrorism Response Act of 2001".
(b) Table of Contents.--The table of contents of the Act is
as follows:
Sec. 1. Short title; table of contents.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
Sec. 101. National preparedness and response.
Sec. 102. Assistant Secretary for Emergency Preparedness; National
Disaster Medical System.
Sec. 103. Improving ability of Centers for Disease Control and
Prevention with respect to bioterrorism and other public
health emergencies; facilities.
Sec. 104. Advisory committees and communications.
Sec. 105. Education of health care personnel; training regarding
pediatric issues.
Sec. 106. Grants regarding shortages of certain health professionals.
Sec. 107. Emergency system for verification of credentials of health
professions volunteers.
Sec. 108. Enhancing preparedness activities for bioterrorism and other
public health emergencies.
Sec. 109. Improving State and local core public health capacities.
Sec. 110. Antimicrobial resistance program.
Sec. 111. Study regarding communications abilities of public health
agencies.
Sec. 112. Supplies and services in lieu of award funds.
Sec. 113. Additional amendments.
Sec. 114. Study regarding local emergency response methods.
Subtitle B--National Stockpile; Development of Priority Countermeasures
Sec. 121. National stockpile.
Sec. 122. Accelerated approval of priority countermeasures.
Sec. 123. Use of animal trials in approval of certain drugs and
biologics; issuance of rule.
Sec. 124. Security for countermeasure development and production.
Sec. 125. Accelerated countermeasure research and development.
Sec. 126. Evaluation of new and emerging technologies regarding
bioterrorist attack and other public health emergencies.
Sec. 127. Potassium iodide.
Subtitle C--Emergency Authorities; Additional Provisions
Sec. 131. Expanded authority of Secretary of Health and Human Services
to respond to public health emergencies.
Sec. 132. Streamlining and clarifying communicable disease quarantine
provisions.
Sec. 133. Emergency waiver of Medicare, Medicaid, and SCHIP
requirements.
Sec. 134. Provision for expiration of public health emergencies.
Sec. 135. Designated State public emergency announcement plan.
Sec. 136. Expanded research by Secretary of Energy.
Sec. 137. Agency for Toxic Substances and Disease Registry.
Sec. 138. Expanded research on worker health and safety.
Sec. 139. Technology opportunities program support.
Subtitle D--Authorization of Appropriations
Sec. 151. Authorization of Appropriations.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Sec. 201. Regulation of certain biological agents and toxins.
TITLE III--AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT
Subtitle A--Protection of Food Supply
Sec. 301. Protection against intentional adulteration of food.
Sec. 302. Administrative detention.
Sec. 303. Permissive debarment regarding food importation.
Sec. 304. Maintenance and inspection of records for foods.
Sec. 305. Registration.
Sec. 306. Prior notice of imported food shipments.
Sec. 307. Authority to mark articles refused admission into United
States.
Sec. 308. Prohibition against port shopping for importation.
Sec. 309. Notices to States regarding imported food.
Sec. 310. Grants to States for inspections; response to notice
regarding adulterated imported food.
Subtitle B--Protection of Drug Supply
Sec. 311. Annual registration of foreign manufacturers; shipping
information; drug and device listing.
Sec. 312. Requirement of additional information regarding import
components intended for use in export products.
TITLE IV--DRINKING WATER SECURITY AND SAFETY
Sec. 401. Amendment of the Safe Drinking Water Act.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.
The Public Health Service Act (42 U.S.C. 201 et seq.) is
amended by adding at the end the following title:
"TITLE XXVIII--NATIONAL 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-
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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) Consultation.--The Secretary shall carry out
paragraph (1) in consultation with the Secretary of Defense,
the Director of the Federal Emergency Management Agency, the
Secretary of Veterans Affairs, the Attorney General, the
Secretary of Agriculture, the Secretary of Energy, the
Secretary of Labor, and the Administrator of the
Environmental Protection Agency, and with other appropriate
public and private entities.
"(3) National approach.--In carrying out paragraph (1),
the Secretary shall collaborate with the States toward the
goal of ensuring that the activities of the Secretary
regarding bioterrorism and other public health emergencies
are coordinated with activities of the States, including
through local governments, such that there is a national plan
for preparedness for and responding effectively to such
emergencies.
"(4) 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)
shall include provisions for achieving the following goals
with respect to preparedness for and responding effectively
to bioterrorism and other public health emergencies:
"(1) Providing effective assistance to State and local
governments in the event of such an emergency.
"(2) Ensuring that State and local governments have
adequate and 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) Adequate laboratory readiness.
"(C) Properly trained and equipped emergency response,
public health, and medical personnel.
"(D) Health and safety protection of workers involved in
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, and
medical devices) against biological agents that may be used
in such emergencies.
"(4) Ensuring coordination and minimizing duplication of
Federal, State, and local planning, preparedness, and
response activities, including among agencies during the
investigation of a suspicious disease outbreak.
"(5) Ensuring adequate readiness of hospitals and other
health care facilities to respond effectively to such
emergencies.
"(c) Evaluation of Using VA R&D Capabilities.--The
Secretary shall evaluate the feasibility of using the
biomedical research and development capabilities of the
Department of Veterans Affairs, in conjunction with that
Department's affiliations with health-professions
universities, as a means to assist the Secretary in achieving
the goals specified in subsection (b).
"(d) Reports to Congress.--
"(1) Initial report to congress.--Not later than one year
after the date of the enactment of the Public Health Security
and Bioterrorism Response Act of 2001, the Secretary shall
submit to the 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) Biennial reports.--Not later than 2 years after the
date on which the report under paragraph (1) is submitted,
and biennially thereafter, the Secretary shall submit to each
of the committees specified in such paragraph a report
concerning the progress made with respect to the plan under
subsection (a), including the goals under subsection (b).
"(3) Additional authority.--Reports submitted under
paragraph (2) by the Secretary shall make recommendations
concerning--
"(A) any additional legislative authority that the
Secretary determines is necessary for fully implementing the
plan under subsection (a), including meeting the goals under
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 that a condition
described in section 319(a) occurs.
"(e) Other Reports.--Not later than one year after the
date of the enactment of the Public Health Security and
Bioterrorism Response Act of 2001, the Secretary shall submit
to each of the committees specified in paragraph (1) a report
concerning--
"(1) the recommendations and findings of the EPIC Advisory
Committee under section 319F(c)(3);
"(2) the characteristics that may render a rural community
uniquely vulnerable to a biological 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
conditions;
"(3) the characteristics that may render areas or
populations designated as medically underserved populations
(as defined in section 330) 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 conditions; and
"(4) the recommendations of the Secretary with respect to
additional legislative authority that the Secretary
determines is necessary to effectively strengthen rural
communities, or medically underserved populations (as defined
in section 330).
"(f) 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
Response Act of 2001, were in effect with respect to
preparing for and responding effectively to bioterrorism and
other public health emergencies.".
SEC. 102. ASSISTANT SECRETARY FOR EMERGENCY PREPAREDNESS;
NATIONAL DISASTER MEDICAL SYSTEM.
(a) In General.--Title XXVIII of the Public Health Service
Act, as added by section 101 of this Act, is amended by
adding at the end the following subtitle:
"Subtitle B--Emergency Preparedness and Response
"SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO
BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES.
"(a) Assistant Secretary for Emergency Preparedness.--
"(1) In general.--There is established within the
Department of Health and Human Services the position of
Assistant Secretary for Emergency Preparedness. The
President, by and with the advice and consent of the Senate,
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 Emergency Preparedness shall
carry out the following duties:
"(A) Coordinate on behalf of the Secretary--
"(i) all interagency interfaces between the Department of
Health and Human Services (referred to in this paragraph as
the `Department') and other departments, agencies and offices
of the United States, including the activities of the joint
interdepartmental working groups under subsections (a) and
(b) of section 319F; and
"(ii) all 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 or 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) Coordinate the activities of the Department with
respect to research and development of priority vaccines,
other biological products, drugs, and devices useful for
detecting or responding to a bioterrorist attack or other
public health emergency.
"(E) Coordinate the activities of the Department with
respect to public education, awareness, and information
relating to bioterrorism or other public health emergencies,
including the activities and recommendations of the EPIC
Advisory Committee under section 319F(c)(3).
"(F) Coordinate all other functions within the Department
of Health and Human Services relating to emergency
preparedness, including matters relating to bioterrorism and
other public health emergencies that are addressed in the
national plan under section 2801.
"(G) 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 (in this
section referred to as the `National System'). The Secretary
shall designate the Assistant Secretary for Emergency
Preparedness as the head of the National System, subject to
the authority of the Secretary.
"(2) Federal and state collaborative system.--
"(A) In general.--The National System shall be a
coordinated effort by the Federal agencies specified in
subparagraph (B), working in collaboration with the States
and other appropriate public or private entities,
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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
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 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 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 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 Response Act of 2001, the
Secretary shall conduct an exercise to test the capability
and timeliness of the National 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 System as the Secretary determines to be
appropriate.
"(c) Criteria.--
"(1) In general.--The Secretary shall establish criteria
for the operation of the National System.
"(2) Education and training of personnel.--In carrying out
paragraph (1), the Secretary shall establish criteria
regarding the education and training of individuals who
provide emergency services through the National System. In
the case of permanent, full-time positions in the Department
of Health and Human Services that involve significant
supervisory roles within the National System, the criteria
shall require that individuals in such positions have
completed appropriate education or training programs as
determined by the Secretary.
"(3) Participation agreements for non-federal entities.--
In carrying out paragraph (1), the Secretary shall establish
criteria regarding the participation of States and private
entities in the National System, including criteria regarding
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 on a reimbursable basis to respond
to emergency situations for which the National System has not
been activated by the Secretary pursuant to subsection
(b)(3)(A).
"(B) Provisions relating to circumstances in which an
individual or entity has agreements with both the National
System and another 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 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 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 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
System or when the individual participates in a training
program authorized by the Assistant Secretary for Emergency
Preparedness or a comparable official of any Federal agency
specified in 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 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) 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).
"(g) Authorization of Appropriations.--For the purpose of
providing for the Assistant Secretary for Emergency
Preparedness and the operations of the National System, other
than purposes for which amounts in the Public Health
Emergency Fund under section 319 are available, there are
authorized to be appropriated such sums as may be necessary
for each of the fiscal years 2002 through 2006.".
(b) Sense of Congress Regarding Resources of National
System.--It is the sense of the Congress that the Secretary
of Health and Human Services should provide sufficient
resources to individuals and entities tasked to carry out the
duties of the National Disaster Medical System for
reimbursement of expenses, operations, purchase and
maintenance of equipment, training, and other funds expended
in furtherance of such National System.
SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL
AND PREVENTION WITH RESPECT TO BIOTERRORISM AND
OTHER PUBLIC HEALTH EMERGENCIES; FACILITIES.
Section 319D of the Public Health Service Act (42 U.S.C.
247d-4) is amended to read as follows:
"SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND
PREVENTION.
"(a) Findings.--Congress finds that the Centers for
Disease Control and Prevention have an essential role in
defending against and combatting public health threats of the
21st century and requires secure and modern facilities, and
expanded and improved capabilities related to biological
threats or attacks or other public health emergencies,
sufficient to enable such Centers to conduct this important
mission.
"(b) Improving the Capacities of the Centers for Disease
Control and Prevention.--
"(1) In general.--The Secretary shall 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;
"(C) improving capabilities for public health surveillance
and reporting activities;
"(D) improving laboratory facilities related to
bioterrorism, including increasing the security of such
facilities; and
"(E) such other activities as the Secretary determines
appropriate.
"(2) Improving public health laboratory capacity.--
"(A) In general.--The Secretary, directly or through
awards of grants, contracts, or cooperative agreements, shall
provide for the
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establishment of a coordinated network of public health
laboratories, that may, at the discretion of the Secretary,
include laboratories that serve as regional reference
laboratories.
"(B) Priority.--In carrying out subparagraph (A), the
Secretary shall give priority to projects that include State
or local government financial commitments, that seek to
incorporate multiple public health and safety services or
diagnostic databases into an integrated public health or
regional reference laboratory, and that cover geographic
areas lacking advanced diagnostic and safety-level laboratory
capabilities.
"(3) National public health communications and
surveillance network.--
"(A) In general.--The Secretary, directly or through
awards of grants, contracts, or cooperative agreements, shall
provide for the establishment of integrated public health
communications and surveillance networks between and among--
"(i) Federal, State, and local public health officials;
"(ii) public and private health-related laboratories,
hospitals, and other health care facilities; and
"(iii) any other entities determined appropriate by the
Secretary.
"(B) Requirements.--The Secretary shall ensure that
networks under subparagraph (A) allow for the timely sharing
and discussion, in a secure manner, of essential information
concerning a bioterrorist attack or other public health
emergency, or recommended methods for responding to such an
attack or emergency.
"(4) Continuity of effort.--To the maximum extent
practicable, the Secretary, in conducting activities under
paragraphs (1) through (3), shall administer such activities
in a manner that intensifies, expands, or enhances activities
being carried out on the date of enactment of this
subsection.
"(c) Facilities.--
"(1) 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 related public
health activities.
"(2) Multiyear contracting authority.--For any project of
designing, constructing, equipping, or renovating any
facility under paragraph (1), 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.
"(d) Authorization of Appropriations.--
"(1) In general.--For the purposes of achieving the
mission of the Centers for Disease Control and Prevention
described in subsection (a), for carrying out subsection (b),
for better conducting the capacities described in section
319A, and for supporting related 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) Facilities.--For the purpose of carrying out
subsection (c), 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.".
SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS.
Section 319F of the Public Health Service Act (42 U.S.C.
247d-6) is amended--
(1) by redesignating subsections (c) through (i) as
subsections (e) through (k), respectively; and
(2) by inserting after subsection (b) the following
subsections:
"(c) Advice to the Federal Government.--
"(1) Required advisory committees.--In coordination with
the working groups under subsections (a) and (b), 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 Response Act of 2001 to meet the special needs
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 Response Act of 2001.
"(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 and report on appropriate ways to communicate
public-health information regarding biological attacks to the
public.
"(C) Composition.--The EPIC Advisory Committee shall be
composed of individuals representing a diverse group of
experts in public health, communications, behavioral
psychology, and other areas determined appropriate by the
Secretary.
"(D) Dissemination.--The Secretary shall ensure that the
recommendations of the EPIC Advisory Committee are widely
disseminated to the media, State and local governments,
poison control centers, and others as the Secretary
determines appropriate.
"(E) Termination.--The EPIC Advisory Committee terminates
one year after the date of the enactment of the Public Health
Security and Bioterrorism Response Act of 2001.
"(d) Strategy for Communication of Information Regarding
Biological Attack.--In coordination with the joint
interdepartmental working group under subsection (b), the
Secretary, acting through the Assistant Secretary for
Emergency Preparedness, shall develop a strategy for
effectively communicating information regarding a biological
attack, and shall develop means by which to communicate such
information. The Secretary may carry out the preceding
sentence directly or through grants, contracts, or
cooperative agreements.".
SEC. 105. EDUCATION OF HEALTH CARE PERSONNEL; TRAINING
REGARDING PEDIATRIC ISSUES.
Section 319F(g) of the Public Health Service Act, as
redesignated by section 104(1) of this Act, is amended to
read as follows:
"(g) Education; Training Regarding Pediatric Issues.--
"(1) Materials; core curriculum.--The Secretary, in
collaboration with members of the working group described in
subsection (b), and professional organizations and societies,
shall--
"(A) develop materials for teaching the elements of a core
curriculum for the recognition and identification (including
proficiency testing) of potential bioweapons and other agents
that may create a public health emergency, and for the care
of victims of such emergencies, 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) provide for dissemination and teaching of the
materials described in subparagraphs (A) and (B) by all
appropriate means, including telemedicine, long-distance
learning, or other such means; and
"(D) to the extent practicable, establish and maintain an
electronic database of individuals participating in training
or education programs carried out under this section, for the
purpose of providing continuing education materials and
information to such participants.
"(2) Grants.--In carrying out paragraph (1), the Secretary
may award grants to, or enter into cooperative agreements
with, professional organizations and societies, private
accrediting organizations, or other nonprofit institutions or
entities meeting criteria established by the Secretary, and
may enter into interagency cooperative agreements with other
Federal agencies.
"(3) Health-Related Assistance for Emergency Response
Personnel Training.--The Secretary, in consultation with the
Attorney General and the Director of the Federal Emergency
Management Agency, may provide assistance with respect to
health-related aspects of emergency response personnel
training carried out by the Department of Justice and the
Federal Emergency Management Agency.".
SEC. 106. GRANTS REGARDING SHORTAGES OF CERTAIN HEALTH
PROFESSIONALS.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.) is amended by inserting after 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,
[[Page H9199]]
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.".
SEC. 107. EMERGENCY SYSTEM FOR VERIFICATION OF CREDENTIALS OF
HEALTH PROFESSIONS VOLUNTEERS.
Part B of title III of the Public Health Service Act, as
amended by section 106 of this Act, is amended by inserting
after section 319H the following section:
"SEC. 319I. EMERGENCY SYSTEM FOR VERIFICATION OF HEALTH
PROFESSIONS VOLUNTEERS.
"(a) In General.--The Secretary shall, directly or through
an award of a grant, contract, or cooperative agreement,
establish and maintain a system for verifying the
credentials, licenses, accreditations, and hospital
privileges of individuals, who during public health
emergencies volunteer to serve as health professionals
(referred to in this section as the `verification system').
In carrying out the preceding sentence, the Secretary shall
provide for an electronic database for the verification
system.
"(b) Certain Criteria.--The Secretary shall establish
criteria regarding the verification system under subsection
(a), including 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) Advance Registration of Volunteers.--In order to
facilitate the availability of health professionals during a
public health emergency, the Secretary shall provide for the
advance registration with the system of health professionals
who are willing to serve as volunteers described in
subsection (a), and may carry out activities to encourage
health professionals to register with the system.
"(d) Other Assistance.--The Secretary may make grants and
provide technical assistance to States and other public or
nonprofit private entities for activities relating to the
verification system developed under subsection (a).
"(e) Coordination Among States.--The Secretary shall
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.
"(f) 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.
"(g) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $2,000,000 for fiscal year 2002, and such sums
as may be necessary for each of the fiscal years 2003 through
2006.".
SEC. 108. ENHANCING PREPAREDNESS ACTIVITIES FOR BIOTERRORISM
AND OTHER PUBLIC HEALTH EMERGENCIES.
Section 319F of the Public Health Service Act (42 U.S.C.
247d-6) is amended--
(1) by amending subsection (a) to read as follows:
"(a) Working Group on Preparedness for Acts of
Bioterrorism.--The Secretary, in coordination with the
Secretary of Defense, the Director of the Federal Emergency
Management Agency, the Attorney General, the Secretary of
Veterans Affairs, the Secretary of Agriculture, the Secretary
of Energy, and the Administrator of the Environmental
Protection Agency shall establish a joint interdepartmental
working group on preparedness and readiness for the medical
and public health effects of a bioterrorist attack on the
civilian population. Such joint working group shall--
"(1) coordinate and prioritize research on, and the
development of countermeasures against, pathogens likely to
be used in a bioterrorist attack on the civilian population;
"(2) facilitate the development, production, and
regulatory review of priority countermeasures (as defined in
subsection (h)(2)(C)) for a bioterrorist attack on the
civilian population;
"(3) coordinate research and development into equipment to
detect pathogens likely to be used in a bioterrorist attack
on the civilian population and protect against infection from
such pathogens;
"(4) develop shared standards for equipment to detect and
to protect against infection from pathogens likely to be used
in a bioterrorist attack on the civilian population; and
"(5) coordinate the development, maintenance, and
procedures for the release and distribution of strategic
reserves of vaccines, drugs, and medical supplies which may
be needed rapidly after a bioterrorist attack upon the
civilian population, including consideration of vulnerable
populations (such as children, the elderly, and individuals
with disabilities).";
(2) in subsection (b)(1), by striking "The Secretary" and
all that follows through "shall establish" and inserting
the following: "The Secretary, in collaboration with the
Secretary of Defense, the Director of the Federal Emergency
Management Agency, the Attorney General, the Secretary of
Veterans Affairs, the Secretary of Agriculture, the Secretary
of Labor, and the Administrator of the Environmental
Protection Agency, shall establish";
(3) in subsection (b)(2)--
(A) in subparagraph (A), by striking "respond to a
bioterrorist attack; and" and inserting the following:
"respond 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) in subparagraph (B), by striking the period and
inserting "; and"; and
(C) by adding at the end the following subparagraph:
"(C) subject to compliance with other provisions of
Federal law, clarify the responsibilities among Federal
officials for the investigation of suspicious outbreaks of
disease, and revise the interagency plan known as the Federal
response plan accordingly.";
(4) in subsection (b)(3), by striking "Assistant Secretary
for Health" and inserting "Assistant Secretary for
Emergency Preparedness"; and
(5) in subsection (e) (as redesignated by section 104(1) of
this Act)--
(A) in paragraph (1), by striking "The Secretary" and all
that follows and inserting the following: "In consultation
with the working group established under subsection (b), the
Secretary shall, based on criteria established by the
Secretary, award grants to or enter into cooperative
agreements with eligible entities to increase their capacity
to detect, diagnose, and respond to acts of bioterrorism upon
the civilian population.";
(B) in paragraph (2)--
(i) by striking "or" after "clinic,"; and
(ii) by inserting before the period the following: ",
professional organizations and societies, schools or programs
that train medical laboratory personnel, private accrediting
organizations, or other nonprofit institutions or entities
meeting criteria established by the Secretary";
(C) in paragraph (3)--
(i) in the matter preceding subparagraph (A), by striking
"the priorities" and inserting "any priorities"; and
(ii) by striking subparagraphs (A) through (D) and
inserting the following:
"(A) developing community-wide plans involving the public
and private health care infrastructure to respond to
bioterrorism or other public health emergencies, which are
coordinated with the capacities of applicable national,
State, and local health agencies;
"(B) training health care professionals and public health
personnel to enhance the ability of such personnel to
recognize the symptoms and epidemiological characteristics of
exposure to a potential bioweapon, or other agents that may
cause a public health emergency;
"(C) addressing rapid and accurate identification of
potential bioweapons, or other agents that may cause a public
health emergency;
"(D) coordinating medical care for individuals during
public health emergencies, including bioterrorism;
"(E) conducting exercises to test the capability and
timeliness of public health emergency response activities;
"(F) facilitating and coordinating rapid communication of
data generated from a bioterrorist attack or public health
emergency among national, State, and local health agencies,
emergency response personnel, and health care providers and
facilities; and
"(G) purchasing or upgrading equipment, supplies,
pharmaceuticals or other countermeasures to enhance
preparedness for and response to bioterrorism or other public
health emergencies, consistent with a plan described in
subparagraph (A)."; and
(D) in paragraph (4)--
(i) in subparagraph (A), by striking "and" after the
semicolon at the end;
(ii) in subparagraph (B), by striking the period at the end
and inserting "; and"; and
(iii) by adding at the end the following subparagraph:
"(C) coordinate grants under this subsection with grants
under 319C.".
SEC. 109. IMPROVING STATE AND LOCAL CORE PUBLIC HEALTH
CAPACITIES.
Section 319C of the Public Health Service Act (42 U.S.C.
247d-3) is amended--
(1) in subsection (a), by striking "competitive "; and
(2) in subsection (c)--
(A) in paragraph (3), by striking "health care providers;
and" and inserting "health care providers, including poison
control centers;";
(B) by redesignating paragraph (4) as paragraph (7); and
(C) by inserting after paragraph (3) the following
paragraphs:
"(4) purchase or upgrade equipment, supplies,
pharmaceuticals or other countermeasures to enhance
preparedness for and response to bioterrorism or other public
health emergencies, consistent with a plan described in
paragraph (3);
[[Page H9200]]
"(5) conduct exercises to test the capability and
timeliness of public health emergency response activities;
"(6) within the meaning of part B of title XII, develop
and implement the trauma care component of the State plan for
the provision of emergency medical services; and";
SEC. 110. ANTIMICROBIAL RESISTANCE PROGRAM.
Section 319E of the Public Health Service Act (42 U.S.C.
247d-5) is amended--
(1) in subsection (b)--
(A) by striking "shall conduct and 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 appropriate
DNA analysis, or other necessary 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.".
SEC. 111. 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 ensure
that 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 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.
SEC. 112. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.
Part B of title III of the Public Health Service Act, as
amended by section 107 of this Act, is amended by 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.".
SEC. 113. ADDITIONAL AMENDMENTS.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq) is amended--
(1) in section 319A(a)(1), by striking "10 years" and
inserting "five years"; and
(2) in section 319B(a), in the first sentence, by striking
"10 years" and inserting "five years".
SEC. 114. STUDY REGARDING LOCAL EMERGENCY RESPONSE METHODS.
The Secretary of Health and Human Services shall conduct a
study of best-practices methods for the provision of
emergency response services through local governments
(including through contractors and volunteers of such
governments) in a consistent manner in response to acts of
bioterrorism or other public health emergencies. Not later
than 180 days after the date of the enactment of this Act,
the Secretary shall submit to the Congress a report
describing the findings of the study.
Subtitle B--National Stockpile; Development of Priority Countermeasures
SEC. 121. NATIONAL STOCKPILE.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the "Secretary") shall
maintain a stockpile or stockpiles of drugs, vaccines and
other biological products, medical devices, and other
supplies in such numbers, types, and amounts as are
determined by the Secretary to be adequate to meet the health
security needs of the United States, including consideration
of vulnerable populations (such as children, the elderly, and
individuals with disabilities), in the event of a
bioterrorist attack or other public health emergency.
(b) Procedures.--The Secretary, in managing the stockpile
under subsection (a), shall--
(1) consult with the Director of the Federal Emergency
Management Agency, the Secretary of Defense, the Secretary of
Veterans Affairs, the Attorney General, the Secretary of
Energy, and the Administrator of the Environmental Protection
Agency;
(2) ensure that adequate procedures are followed with
respect to such stockpile for inventory management and
accounting, and for the physical security of the stockpile;
(3) in consultation with Federal, State, and local
officials, take into consideration the timing and location of
special events;
(4) review and revise, as appropriate, the contents of the
stockpile on a regular basis to ensure that emerging threats,
advanced technologies, and new countermeasures are adequately
considered; and
(5) devise plans for the effective and timely distribution
of the stockpile, in consultation with appropriate Federal,
State and local agencies, and the public and private health
care infrastructure.
(c) Definition.--For purposes of subsection (a), the term
"stockpile" includes--
(1) a physical accumulation (at one or more 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).
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $1,155,000,000 for fiscal year 2002, and such
sums as may be necessary for each of fiscal years 2003
through 2006.
SEC. 122. ACCELERATED APPROVAL OF PRIORITY COUNTERMEASURES.
(a) In General.--The Secretary of Health and Human Services
may designate a priority countermeasure as a fast-track
product pursuant to section 506 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356). Such a designation may be
made prior to the submission of--
(1) a request for designation by the sponsor; or
(2) an application for the investigation of the drug under
section 505(i) of such Act or section 351(a)(3) of the Public
Health Service Act. Nothing in this subsection shall be
construed to prohibit a sponsor from declining such a
designation.
(b) Review of Priority Countermeasure Not Designated as
Fast-Track Product.--A priority countermeasure shall be
subject to the performance goals established by the
Commissioner of Food and Drugs, unless it is designated as a
fast-track product.
(c) Definition.--For purposes of this section, the term
"priority countermeasure" means a drug or biological
product that is a countermeasure 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.
SEC. 123. USE OF ANIMAL TRIALS IN APPROVAL OF CERTAIN DRUGS
AND BIOLOGICS; ISSUANCE OF RULE.
Not later than 180 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 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).
SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND
PRODUCTION.
Part B of title III of the Public Health Service Act, as
amended by section 112 of this Act, is amended by inserting
after section 319J the following section:
"SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND
PRODUCTION.
"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)(2)(C)).".
SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND
DEVELOPMENT.
Section 319F(h) of the Public Health Service Act, as
redesignated by section 104(1) of this Act, is amended--
(1) by redesignating paragraphs (1) through (4), as
subparagraphs (A) through (D), respectively;
(2) by striking "The Secretary" and inserting the
following:
"(1) In general.--The Secretary";
(3) by moving each of subparagraphs (A) through (D) (as so
redesignated) two ems to the right; and
(4) by adding at the end the following:
"(2) Accelerated countermeasure research and
development.--
"(A) 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--
"(i) the epidemiology and pathogenesis of such pathogens;
[[Page H9201]]
"(ii) the development of new vaccines and therapeutics for
use against such pathogens and other agents;
"(iii) the development of diagnostic tests to detect such
pathogens and other agents; and
"(iv) other relevant areas of research;
with consideration given to the needs of children and other
vulnerable populations.
"(B) Role of department of veterans affairs.--In carrying
out subparagraph (A), 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 subparagraph, the
Secretary may enter into cooperative agreements with the
Secretary of Veterans Affairs to achieve such purposes.
"(C) Priority countermeasures.--For purposes of this
paragraph, the term `priority countermeasure' means a
countermeasure, including a drug, medical or other
technological device, biological product, or diagnostic test,
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.".
SEC. 126. EVALUATION OF NEW AND EMERGING TECHNOLOGIES
REGARDING 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 evaluate new and emerging
technologies that are designed to improve or enhance the
ability of public health or safety officials to detect,
identify, diagnose, or conduct public health surveillance
activities relating to a bioterrorist attack or other public
health emergency.
(b) Certain Activities.--In carrying out this subsection,
the Secretary shall--
(1) survey existing technology programs funded by the
Federal Government for potentially useful technologies;
(2) promptly issue a request for information from non-
Federal public and private entities for 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 joint
interdepartmental working group under section 319F(a) of the
Public Health Service Act, as well as other appropriate
public, nonprofit, and private entities, to 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, 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 that provides a
list of priority technologies whose development or deployment
or both should be accelerated, and the estimated cost of
doing so.
SEC. 127. POTASSIUM IODIDE.
(a) In General.--Through the national stockpile under
section 121, the Secretary of Health and Human Services (in
this section referred to as the "Secretary"), subject to
subsection (b), shall make available to State and local
governments potassium iodide tablets for stockpiling and for
distribution as appropriate to public facilities, such as
schools and hospitals, that are within 20 miles of a nuclear
power plant, in quantities sufficient to provide adequate
protection for the populations within such miles.
(b) State and Local Plans.--Subsection (a) applies with
respect to a State or local government if the government
involved meets the following conditions:
(1) Such government submits to the Secretary, and to the
Director of the Federal Emergency Management Agency, 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.
(2) The plan is accompanied by certifications by such
government that--
(A) the government has not received sufficient quantities
of potassium iodide tablets from the Nuclear Regulatory
Commission; and
(B) in the case of a local government, such government has
submitted the plan to the State involved.
(c) Guidelines.--In consultation with the Director of the
Federal Emergency Management Agency and with the Nuclear
Regulatory Commission, the Secretary shall establish
guidelines for the stockpiling of potassium iodide tablets,
and for the distribution and utilization of potassium iodide
tablets in the event of a nuclear incident.
(d) Information.--The Secretary shall carry out activities
to inform State and local governments of the program under
this section.
(e) Report.--Not later than six months after the date of
the enactment of this Act, the Secretary shall submit to the
Congress a report--
(1) on whether potassium iodide tablets have been made
available under subsection (a) and the extent to which State
and local governments have established stockpiles of such
tablets; and
(2) the measures taken by the Secretary to implement this
section.
(f) Applicability.--Subsections (a) and (d) cease to apply
as requirements if the Secretary determines that there is an
alternative and more effective medical treatment to address
adverse thyroid conditions that may result from the release
of radionuclides from nuclear power plants.
Subtitle C--Emergency Authorities; Additional Provisions
SEC. 131. EXPANDED AUTHORITY OF SECRETARY OF HEALTH AND HUMAN
SERVICES TO RESPOND TO PUBLIC HEALTH
EMERGENCIES.
(a) Transfers of Funds.--Section 319 of the Public Health
Service Act (42 U.S.C. 247d) is amended by adding at the end
the following:
"(d) Transfers of Funds Between Programs and Accounts.--
"(1) In general.--At any time during a public health
emergency declared by the Secretary under subsection (a), the
Secretary may, subject to paragraph (2), transfer funds, to
the extent authorized by law, between appropriations accounts
administered by the Secretary under this Act, without regard
to any waiting period imposed by any other provision of law,
including any provision of an appropriations Act, except as
provided in paragraphs (3) and (4).
"(2) Amount of transfers.--With respect to the public
health emergency involved:
"(A) The Secretary may not make a transfer under paragraph
(1) in an amount exceeding a reasonable estimate by the
Secretary of the amount necessary to respond to the emergency
involved for a period of 60 days.
"(B) Subsequent transfers under paragraph (1) may be made
by the Secretary, subject to compliance with subparagraph
(A).
"(3) Notification.--Not later than 48 hours prior to
making a transfer under paragraph (1), the Secretary shall
submit a notice of the intent to make such transfer to the
Committee on Appropriations of the House of Representatives,
the Committee on Energy and Commerce of the House of
Representatives, the Committee on Appropriations of the
Senate, and the Committee on Health, Education, Labor, and
Pensions of the Senate.
"(4) Scope.--Paragraph (1) shall apply, notwithstanding
any other provision of law including any provision of an
appropriations Act and any Act enacted after the date of
enactment of this subsection, unless such provision
specifically refers to and overrides this subsection.".
(b) Reporting Deadlines.--Section 319 of the Public Health
Service Act (42 U.S.C. 247d), as amended by subsection (a),
is further amended by adding at the end the following:
"(e) Data Submittal and Reporting Deadlines.--In any case
in which the Secretary determines that, wholly or partially
as a result of a public health emergency that has been
declared pursuant to subsection (a), individuals or public or
private entities are unable to comply with deadlines for the
submission to the Secretary of data or reports required under
any law administered by the Secretary, the Secretary may,
notwithstanding any other provision of law, grant such
extensions of such 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.".
SEC. 132. STREAMLINING AND CLARIFYING COMMUNICABLE DISEASE
QUARANTINE PROVISIONS.
(a) Elimination of Prerequisite for National Advisory
Health Council Recommendation Before Issuing Quarantine
Rules.--
(1) Executive orders specifying diseases subject to
individual detentions.--Section 361(b) of the Public Health
Act (42 U.S.C. 264(b)) is amended by striking "Executive
orders of the President upon the recommendation of the
National Advisory Health Council and the Surgeon General"
and inserting "Executive orders of the President upon the
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 by inserting "or exposed to" after "to be infected
with".
(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
inserting "or exposed to" after "to be infected with".
(c) State Authority.--Section 361 of the Public Health Act
(42 U.S.C. 264) is amended by adding at the end the
following:
"(e) Nothing in this section or section 363, or the
regulations promulgated under such
[[Page H9202]]
sections, may be construed as superseding any provision under
State law (including regulations and including provisions
established by political subdivisions of States), except to
the extent that such a provision conflicts with an exercise
of Federal authority under this section or section 363.".
SEC. 133. EMERGENCY WAIVER OF MEDICARE, MEDICAID, AND SCHIP
REQUIREMENTS.
(a) Waiver Authority.--Title XI of the Social Security Act
(42 U.S.C. 1301 et seq.) is amended by inserting after
section 1134 the following new section:
"SEC. 1135. AUTHORITY TO WAIVE REQUIREMENTS DURING NATIONAL
EMERGENCIES.
"(a) Purpose.--
"(1) In general.--The purpose of this section is to enable
the Secretary to ensure to the maximum extent feasible, in
any emergency area and during an emergency period--
"(A) that sufficient health care items and services are
available to meet the needs of individuals in such area
enrolled in the programs under titles XVIII, XIX, and XXI;
and
"(B) that health care providers (as defined in subsection
(g)) that furnish such items and services in good faith, but
that are unable to comply with one or more requirements
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.
"(2) Emergency area; emergency period.--For purposes of
this section, 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.
"(b) Secretarial Authority.--To the extent necessary to
accomplish the purposes specified in subsection (a), the
Secretary is authorized, subject to the provisions of this
section, to temporarily waive or modify the application of,
with respect to health care items and services furnished in
any emergency area (or portion of such an area) during an
emergency period, the requirements of titles XVIII, XIX, or
XXI, or any regulation thereunder (and the requirements of
this title, and regulations thereunder, insofar as they
relate to such titles), pertaining to--
"(1) conditions of participation or other certification
requirements for an individual health care provider or types
of providers; program participation and similar requirements
for an individual health care provider or types of providers;
and pre-approval requirements;
"(2) requirements that physicians and other health care
professionals be licensed in the State in which they provide
such services, if they have equivalent licensing in another
State;
"(3) sanctions under section 1867 (relating to examination
and treatment for emergency medical conditions and women in
labor) for a transfer of an individual who has not been
stabilized in violation of subsection (c) of such section if
the transfer arises out of the circumstances of the
emergency;
"(4) sanctions under section 1877(g) (relating to
limitations on physician referral); and
"(5) deadlines and timetables for performance of required
activities, except that such deadlines and timetables may
only be modified, not waived.
"(c) Authority for Retroactive Waiver.--A waiver or
modification of requirements pursuant to this section may, at
the Secretary's discretion, be made retroactive to the
beginning of the emergency period or any subsequent date in
such period specified by the Secretary.
"(d) Notification of Congress.--The Secretary shall
provide advance written notice to the Congress at least two
days before exercising the authority under this section with
respect to an emergency area. Such a notice shall include a
description of the specific provisions that will be waived or
modified, the health care providers to whom the waiver or
modification will apply, the geographic area in which the
waiver or modification will apply, and the period of time for
which the waiver or modification will be in effect.
"(e) Duration of Waiver.--
"(1) In general.--A waiver or modification of requirements
pursuant to this section terminates upon--
"(A) the termination of the applicable declaration of
emergency or disaster described in subsection (a)(2)(B);
"(B) the termination of the applicable declaration of
public health emergency described in subsection (a)(2)(B); or
"(C) subject to paragraph (2), the termination of a period
of 90 days from the date the waiver or modification is first
published (or, if applicable, the date of extension of the
waiver or modification under paragraph (2)).
"(2) Extension of 90-day periods.--The Secretary may, by
notice, provide for an extension of a 90-day period described
in paragraph (1)(C) (or an additional period provided under
this paragraph) for additional period or periods (not to
exceed, except as subsequently provided under this paragraph,
90 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 the success of
such approaches and recommendations for improved approaches
should the need for such emergency authority arise in the
future.
"(g) Health Care Provider Defined.--For purposes of this
section, the term `health care provider' means any entity
that furnishes health care items or services, and includes a
hospital or other provider of services, a 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 amendments made by subsection (a)
shall be effective on and after September 11, 2001.
SEC. 134. PROVISION FOR EXPIRATION OF PUBLIC HEALTH
EMERGENCIES.
Section 319(a) of the Public Health Service Act (42 U.S.C.
247d(a)), is amended by adding at the end the 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.".
SEC. 135. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT
PLAN.
Section 613(b) of the Robert T. Stafford Disaster Relief
and Emergency Assistance Act (42 U.S.C. 5196b(b)) is
amended--
(1) in paragraph (5), by striking "and" at the end;
(2) in paragraph (6), by striking the period and inserting
"; and"; and
(3) by adding at the end the following:
"(7) include a plan for providing information to the
public in a coordinated manner.".
SEC. 136. EXPANDED RESEARCH BY SECRETARY OF ENERGY.
(a) In General.--In coordination with the joint
interdepartmental working group under section 319F(a) of the
Public Health Service Act, the Secretary of Energy and the
Administrator of the National Nuclear Security Administration
shall expand, enhance, and intensify 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.
(b) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 2002 through 2006.
SEC. 137. AGENCY FOR TOXIC SUBSTANCE AND DISEASE REGISTRY.
(a) In General.--In planning for and responding to
bioterrorism and other public health emergencies, including
assisting State health departments, the Secretary of Health
and Human Services (in this section referred to as the
"Secretary") shall take into account the role and expertise
of the Agency for Toxic Substances and Disease Registry (in
this section referred to as "ATSDR").
(b) Authorization of Appropriations.--For the purpose of
providing resources (including increased personnel, as
appropriate) for ATSDR to use authorities under section
104(i) of the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980 to assist the
Secretary in planning for or responding to bioterrorism or
other public health emergencies, there are authorized to be
appropriated to the Secretary such sums as may be necessary
for each of the fiscal years 2002 through 2006, in addition
to any other authorizations of appropriations that are
available for such purpose.
SEC. 138. EXPANDED RESEARCH ON WORKER HEALTH AND SAFETY.
The Secretary, acting through the Director of the 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.
SEC. 139. TECHNOLOGY OPPORTUNITIES PROGRAM SUPPORT.
For fiscal years 2003 and 2004, all of the information
infrastructure grants provided by the National
Telecommunications and Information Administration (under the
program also known as the Technology Opportunities Program)
shall be used to provide grants to health providers to
facilitate participation in the national public health
communications and surveillance networks authorized under
section 319D(b)(3) of the Public Health Service Act.
Subtitle D--Authorization of Appropriations
SEC. 151. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--For the purpose of carrying out activities
of the Department of Health and Human Services in accordance
with the provisions referred to in subsection (b), including
making awards of grants, cooperative agreements, or contracts
and providing other assistance to States and other public or
private entities, there are authorized to be appropriated
$2,720,000,000 for fiscal year 2002, and such sums as may be
necessary for each of the fiscal years 2003 through 2006.
(b) Relevant Provisions.--For purposes of this section, the
provisions referred to in this subsection are--
[[Page H9203]]
(1) the provisions of this title;
(2) sections 319A through 319K of the Public Health Service
Act;
(3) title XXVIII of such Act; and
(4) section 301 of such Act, to the extent that such
section is used as the authority of the Secretary of Health
and Human Services to carry out activities to supplement the
activities carried out under the provisions referred to in
paragraphs (1) through (3);
except that this section does not have any applicability with
respect to the use of section 301 of such Act as authority
for activities of the National Institutes of Health.
(c) Fiscal Year 2002.--
(1) In general.--The aggregate amount of authorizations of
appropriations under this title and under the Public Health
Service Act for fiscal year 2002 for the purpose described in
subsection (a) does not exceed the amount specified for
fiscal year 2002 in such subsection, notwithstanding other
authorizations of appropriations.
(2) Allocations of authorizations.--Of the amount that is
authorized to be appropriated under subsection (a) for fiscal
year 2002, the following authorizations of appropriations for
such fiscal year for the purpose described in such subsection
apply:
(A) For making awards of grants, cooperative agreements, or
contracts and providing other assistance to States and other
public or private entities, $1,000,000,000 is authorized, of
which--
(i) $455,000,000 is authorized for grants under section
319C of the Public Health Service Act;
(ii) $455,000,000 is authorized for grants or cooperative
agreements under section 319F of such Act; and
(iii) $40,000,000 is authorized for grants or cooperative
agreements under section 319H of the Public Health Service
Act, as added by section 106 of this Act (relating to
shortages of certain health professionals).
(B) For the national stockpile under section 121 of this
Act, other than activities of the National Institutes of
Health regarding smallpox vaccine, $1,155,000,000 is
authorized, of which $509,000,0000 is authorized for the
acquisition of smallpox vaccine.
(C) For the Centers for Disease Control and Prevention,
other than purposes to which the authorization established in
subparagraph (A) applies, $450,000,000, of which $300,000,000
is authorized for facilities of such Centers for purposes
described in section 399D(c) of the Public Health Service
Act.
(D) For activities on antimicrobial resistance under
section 319E of such Act, $25,000,000 is authorized.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.
(a) Biological Agents Provisions of the Antiterrorism and
Effective Death Penalty Act of 1996; Codification in the
Public Health Service Act, With Amendments.--
(1) Public health service act.--Subpart 1 of part F of
title III of the Public Health Service Act (42 U.S.C. 262 et
seq.) is amended by inserting after section 351 the
following:
"SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS
AND TOXINS.
"(a) Regulatory Control of Certain Biological Agents and
Toxins.--
"(1) List of biological agents and toxins.--
"(A) In general.--The Secretary shall by regulation
establish and maintain a list of each biological agent and
each toxin that has the potential to pose a severe threat to
public health and safety.
"(B) Criteria.--In determining whether to include an agent
or toxin on the list under subparagraph (A), the Secretary
shall--
"(i) consider--
"(I) the effect on human health of exposure to the agent
or toxin;
"(II) the degree of contagiousness of the agent or toxin
and the methods by which the agent or toxin is transferred to
humans;
"(III) the availability and effectiveness of immunizations
to prevent and treatments for any illness resulting from
infection by the agent or toxin; and
"(IV) any other criteria that the Secretary considers
appropriate; and
"(ii) consult with scientific experts representing
appropriate professional groups.
"(2) Biennial publication.--The Secretary shall publish
the list under paragraph (1) biennially, or at such more
frequent intervals as the Secretary determines to be
appropriate. Before publishing the list, the Secretary shall
review the list, and shall make such revisions as are
appropriate to protect the public health and safety. In
reviewing and revising the list, the Secretary shall consider
the needs of vulnerable populations, including children, and
shall consult with appropriate Federal agencies and State and
local public health officials.
"(b) Regulation of Transfers of Listed Biological Agents
and Toxins.--The Secretary shall by regulation provide for--
"(1) the establishment and enforcement of safety
procedures for the transfer of biological agents and toxins
listed pursuant to subsection (a)(1), including measures to
ensure--
"(A) proper training and appropriate skills to handle such
agents and toxins; and
"(B) proper laboratory facilities to contain and dispose
of such agents and toxins;
"(2) safeguards to prevent access to such agents and
toxins for use in domestic or international terrorism or for
any other criminal purpose;
"(3) the establishment of procedures to protect the public
safety in the event of a transfer or potential transfer of a
biological agent or toxin in violation of the safety
procedures established under paragraph (1) or the safeguards
established under paragraph (2); and
"(4) appropriate availability of biological agents and
toxins for research, education, and other legitimate
purposes.
"(c) Possession and Use of Listed Biological Agents and
Toxins.--The Secretary shall by regulation provide for the
establishment and enforcement of standards and procedures
governing the possession and use of biological agents and
toxins listed pursuant to subsection (a)(1) in order to
protect the public health and safety, including the measures,
safeguards, procedures, and availability of such agents and
toxins described in paragraphs (1) through (4) of subsection
(b), respectively.
"(d) Registration and Traceability Mechanisms; Database.--
Regulations under subsections (b) and (c) shall require
registration of the possession, use, and transfer of
biological agents and toxins listed pursuant to subsection
(a)(1), and such registration shall include (if available to
the registered person) information regarding the
characterization of such biological agents and toxins to
facilitate their identification and traceability. The
Secretary shall maintain a national database of the location
of such agents and toxins, with information regarding their
characterizations.
"(e) Inspections.--The Secretary may conduct inspections
to ensure that persons subject to regulations under
subsection (b) or (c) are in compliance with such
regulations, including provisions regarding security and
restrictions on access under subsection (g).
"(f) Exemptions.--The Secretary may establish exemptions
from the applicability of provisions of regulations under
subsection (b) or (c) if the Secretary determines that such
exemptions are consistent with protecting the public health
and safety. In the case of a clinical laboratory that is in
possession of a biological agent or toxin listed pursuant to
subsection (a)(1), such an exemption may be provided only if
such agent or toxin has been presented for diagnosis,
verification, or proficiency testing, and upon identification
or verification of the agent or toxin, such laboratory--
"(1) promptly notifies the Secretary or other public
health authorities when required under Federal or State law;
and
"(2) transfers or destroys the agent or toxin in
accordance with such regulations.
"(g) Security Requirements for Registered Persons.--
"(1) In general.--In carrying out the provisions of
subsections (b) and (c) that relate to safeguards, the
Secretary, in consultation with the Attorney General, shall
by regulation establish appropriate security requirements for
persons possessing, using, or transferring biological agents
or toxins listed pursuant to subsection (a)(1), and ensure
compliance with such requirements as a condition of
registration under subsection (b) or (c).
"(2) Limiting access to listed agents and toxins.--
"(A) In general.--Regulations issued under subsections (b)
and (c) shall include provisions--
"(i) to restrict access to biological agents and toxins
listed pursuant to subsection (a)(1) to only those
individuals who have a legitimate need for access, as
determined according to the purposes for which the
registration under such regulations is provided; and
"(ii) to ensure that individuals granted such access are
not--
"(I) restricted persons, as defined in section 175b of
title 18, United States Code;
"(II) named in a warrant issued to a Federal or State law
enforcement agency for participation in any domestic or
international act of terrorism or other act of violence;
"(III) under investigation for involvement with a domestic
or international terrorist or criminal organization by any
Federal law enforcement or intelligence agency; or
"(IV) suspected by any Federal law enforcement or
intelligence agency of seeking to obtain covertly information
relating to biological agents or toxins on behalf of the
intelligence or military operations of a foreign nation.
"(B) Screening protocol.--To carry out subparagraph (A),
the Secretary shall require that registered persons promptly
submit the names and other identifying information for
individuals described in subparagraph (A)(i) to the Secretary
and the Attorney General, with which information the Attorney
General shall promptly use criminal, immigration, and
national security databases available to the Federal
Government to identify whether such individuals satisfy the
conditions for access under subparagraph (A)(ii). The
Secretary, in consultation with the Attorney General and
other Federal agencies, shall periodically review and as
appropriate revise the protocol for screening individuals for
purposes of subparagraph (A), and may require by regulation
additional screening measures if determined necessary to
achieve the purposes of this section.
"(3) Assistance for certain entities.--The Secretary, in
consultation with the Attorney General, may make awards of
grants, contracts, or cooperative agreements to public and
nonprofit private entities (other than Federal agencies), and
may provide technical assistance to such entities, to improve
security of the facilities of registered persons.
[[Page H9204]]
"(h) Disclosure of Information.--
"(1) In general.--Any information in the possession of any
Federal agency that identifies a person, or the geographic
location of a person, who is registered pursuant to
regulations under this section (including regulations
promulgated before the effective date of this subsection),
and any site-specific information relating to the type,
quantity, or identity of a biological agent or toxin listed
pursuant to subsection (a)(1) or the site-specific security
mechanisms in place to protect such agents and toxins, shall
not be disclosed under section 552(a) of title 5, United
States Code.
"(2) Disclosures for public health and safety; congress.--
Nothing in this section may be construed as preventing the
head of any Federal agency--
"(A) from making disclosures of information described in
paragraph (1) for purposes of protecting the public health
and safety; or
"(B) from making disclosures of such information to any
committee or subcommittee of the Congress with appropriate
jurisdiction, upon request.
"(i) Civil Money Penalty.--
"(1) In general.--In addition to any other penalties that
may apply under law, any person who violates any provision of
regulations under subsection (b) or (c) shall be subject to
the United States for a civil money penalty in an amount not
exceeding $250,000 in the case of an individual and $500,000
in the case of any other person.
"(2) Applicability of certain provisions.--The provisions
of section 1128A of the Social Security Act (other than
subsections (a), (b), (h), and (i), the first sentence of
subsection (c), and paragraphs (1) and (2) of subsection (f))
shall apply to a civil money penalty under paragraph (1) in
the same manner as such provisions apply to a penalty or
proceeding under section 1128A(a) of such Act. The Secretary
may delegate authority under this subsection in the same
manner as provided in section 1128A(j)(2) of the Social
Security Act, and such authority shall include all powers as
contained in section 6 of the Inspector General Act of 1978.
"(j) Coordination With Regulations Under Virus-Serum-Toxin
Act.--
"(1) In general.--In establishing and enforcing
regulations under subsections (b) and (c), the Secretary
shall consult with the Secretary of Agriculture to ensure
that such activities are coordinated, to the greatest extent
practicable, with regulations governing certain biological
agents and toxins listed pursuant to subsection (a)(1) issued
by the Secretary of Agriculture under the Act commonly known
as the Virus-Serum-Toxin Act (the eighth paragraph under the
heading `Bureau of Animal Industry' in the Act of March 4,
1913; 21 U.S.C. 151-159) (in this subsection referred to as
the `VST Act'). The purpose of such coordination shall be--
"(A) to minimize any conflicts between the regulations
issued by, or the activities of, the Secretary of Health and
Human Services and the Secretary of Agriculture with respect
to such agents and toxins;
"(B) to minimize the administrative burden on persons
subject to regulations under both this section and the VST
Act;
"(C) to ensure the appropriate availability of such agents
and toxins for legitimate agricultural or veterinary
research, education, or other such purposes; and
"(D) to ensure the establishment of a national database of
such agents or toxins pursuant to subsection (d).
"(2) Persons regulated by department of agriculture.--With
respect to persons possessing or using biological agents or
toxins listed pursuant to subsection (a)(1) who, as of the
date of enactment of the Public Health Security and
Bioterrorism Response Act of 2001, possess an unexpired,
unrevoked, and unsuspended permit or license from the
Department of Agriculture for such possession or use, such
persons may, for purposes of registration under subsection
(b) or (c), submit to the Secretary of Health and Human
Services the same information previously provided to the
Secretary of Agriculture to obtain such permit or license,
provided that the information so submitted is accurate as of
the time of submittal to the Secretary of Health and Human
Services, and provided further that such Secretary may, after
review of such submission, request such additional
information as the Secretary determines to be necessary to
achieve the purposes of this section.
"(3) Savings provision.--Nothing in this section shall be
construed as limiting any authority of the Secretary of
Agriculture under the VST Act or any regulations issued
thereunder.
"(k) Definitions.--For purposes of this section:
"(1) The terms `biological agent' and `toxin' have the
meanings given such terms in section 178 of title 18, United
States Code.
"(2) The term `registered person' means a person
registered under regulations under subsection (b) or (c).
"(l) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2006.".
(2) Relation to other laws.--
(A) Rule of construction.--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 paragraph (1) of this
subsection. Such regulations, including the list under
subsection (d)(1) of such section 511, that were in effect on
the day before the date of the enactment of this Act remain
in effect until modified by the Secretary (including any
revisions required under subsection (a)(2) of such section
351A).
(B) Conforming amendment.--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.
(3) Date certain for promulgation of certain regulations;
effective date regarding criminal and civil penalties.--With
respect to section 351A of the Public Health Service Act (as
added by paragraph (1) of this subsection):
(A) Not later than 30 days after the date of the enactment
of this Act, the Secretary of Health and Human Services shall
promulgate an interim final rule requiring all persons in
possession of biological agents or toxins listed pursuant to
subsection (a)(1) of such section (unless exempt under
subsection (e) of such section) to provide notice to the
Secretary of such possession, and to include in the notice
such additional information as the Secretary may require for
compliance with subsection (d) of such section or any other
provision of such section, by not later than 30 days after
the date on which such rule is promulgated. Such interim
final rule takes effect on the date on which the rule is
promulgated, except as follows:
(i) For purposes of section 175b(c) of title 18, United
States Code (relating to criminal penalties), as added by
subsection (a)(1)(E) of this section, the rule takes effect
60 days after the date on which the rule is promulgated.
(ii) For purposes of subsection (i) of such section 351A
(relating to civil penalties), the rule takes effect 60 days
after the date on which the rule is promulgated.
(B) Not later than 120 days after the date of enactment of
this Act, such Secretary shall promulgate an interim final
rule for carrying out subsections (b) and (c) of such section
351A. Such interim final rule takes effect 60 days after the
date on which the rule is promulgated.
(4) Effective date regarding disclosure of information.--
Subsection (h) of section 351A of the Public Health Service
Act, as added by paragraph (1) of this subsection, is deemed
to have taken effect on the effective date of the
Antiterrorism and Effective Death Penalty Act of 1996.
(b) Criminal Penalties Regarding Select Agents.--
(1) In general.--Section 175b of title 18, United States
Code, as added by section 817 of Public Law 107-56, is
amended--
(A) by striking "(a)" and inserting "(a)(1)";
(B) by transferring subsection (c) from the current
placement of the subsection and inserting the subsection
before subsection (b);
(C) by striking "(c)" and inserting "(2);
(D) by redesignating subsection (b) as subsection (d); and
(E) by inserting before subsection (d) (as so redesignated)
the following subsections:
"(b) Transfer to Unregistered Person.--Whoever knowingly
transfers a select agent to a person without first verifying
with the Secretary of Health and Human Services that the
person has obtained a registration 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.
"(c) Unregistered for Possession.--Whoever knowingly
possesses a biological agent or toxin where such agent or
toxin is a select agent for which such person has not
obtained a registration required by regulations under section
351A(c) of the Public Health Service Act shall be fined under
this title, or imprisoned for not more than 5 years, or
both.".
(2) Conforming amendments.--Chapter 10 of title 18, United
States Code, is amended--
(A) in section 175b (as added by section 817 of Public Law
107-56 and amended by paragraph (1) of this subsection)--
(i) in subsection (d)(1), by striking "The term" and all
that follows through "does not include" and inserting the
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
(ii) in the heading for the section, by striking
"Possession by restricted persons" and inserting "Select
agents"; and
(B) in the chapter analysis, in the item relating to
section 175b, by striking "Possession by restricted
persons." and inserting "Select agents.".
(3) Technical corrections.--Chapter 10 of title 18, United
States Code, as amended by section 817 of Public Law 107-56
and paragraphs (1) and (2) of this subsection, is amended--
(A) in section 175--
(i) in subsection (a), in the second sentence, by striking
"this section" and inserting "this subsection"; and
(ii) in subsection (c), by striking "protective" and all
that follows and inserting "protective, bona fide research,
or other peaceful purposes.";
(B) in section 175b--
(i) in subsection (a)(1), by striking "described in
subsection (b)" and all that follows and inserting the
following: "shall ship or transport in or affecting
interstate or foreign commerce, or possess in or affecting
interstate or foreign commerce, any biological agent or
toxin, or receive any biological agent or toxin that has been
shipped or
[[Page H9205]]
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
(ii) in subsection (d)(3), by striking "section
1010(a)(3)" and inserting "section 101(a)(3)";
(C) in section 176(a)(1)(A), by striking "exists by reason
of" and inserting "pertains to"; and
(D) in section 178--
(i) in paragraph (1), by striking "means any micro-
organism" and all that follows through "product, capable
of" and inserting the following: "means any 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";
(ii) in paragraph (2), by striking "means the toxic" and
all that follows through "including--" and inserting the
following: "means the toxic material or product of plants,
animals, microorganisms (including, but not limited to,
bacteria, viruses, fungi, rickettsiae or protozoa), or
infectious substances, or a recombinant or synthesized
molecule, whatever their origin and method of production, and
includes--"; and
(iii) in paragraph (4), by striking "recombinant
molecule," and all that follows through "biotechnology,"
and inserting "recombinant or synthesized molecule,".
(4) Additional technical correction.--Section 2332a of
title 18, United States Code, is amended--
(A) in subsection (a), in the matter preceding paragraph
(1), by striking "section 229F)" and all that follows
through "section 178)--" and inserting "section 229F)--";
and
(B) in subsection (c)(2)(C), by striking "a disease
organism" and inserting "a biological agent, toxin, or
vector (as those terms are defined in section 178 of this
title)".
(c) Security Upgrades at the Department of Health and Human
Services.--For the purpose of enabling the Secretary of
Health and Human Services to secure existing facilities of
the Department of Health and Human Services where biological
agents or toxins listed under section 351A(a)(1) of the
Public Health Service Act are housed or researched, or where
vaccines are housed or researched, there are authorized to be
appropriated such sums as may be necessary for fiscal year
2002 and each subsequent fiscal year.
(d) Report to Congress.--Not later than 1 year after the
date of the enactment of this Act, the Secretary of Health
and Human Services, after consultation with other appropriate
Federal agencies, shall submit to the Congress a report
that--
(1) describes the extent to which there has been compliance
by governmental and private entities with applicable
regulations under section 351A of the Public Health Service
Act (as added by subsection (a) of this section), including
the extent of compliance before the date of the enactment of
this Act, and including the extent of compliance with
regulations promulgated after such date of enactment;
(2) describes the actions to date and future plans of the
Secretary for updating the list of biological agents and
toxins under such section 351A;
(3) describes the actions to date and future plans of the
Secretary for determining compliance with regulations under
such section 351A and for taking appropriate enforcement
actions; and
(4) provides any recommendations of the Secretary for
administrative or legislative initiatives regarding such
section 351A.
TITLE III-AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT
Subtitle A--Protection of Food Supply
SEC. 301. PROTECTION AGAINST INTENTIONAL ADULTERATION OF
FOOD.
(a) Increasing Inspections for Detection of Intentional
Adulteration of Food.--Section 801 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381) is amended by adding at the
end the following 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 paragraphs:
"(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.
"(3) The Secretary shall submit to the Committee on Energy
and Commerce of the House of Representatives, and the
Committee on Health, Education, Labor, and Pensions of the
Senate, periodic reports describing the activities of the
Secretary under paragraphs (1) and (2).".
(c) Testing for Rapid Detection of Intentional 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).".
(d) Assessment of Threat of Intentional Adulteration of
Food.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall ensure
that, not later than six months after the date of the
enactment of this Act--
(1) the assessment that (as of such date of 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.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section and the amendments made by this
section, there are authorized to be appropriated $100,000,000
for fiscal year 2002, and such sums as may be necessary for
each of the fiscal years 2003 through 2006, in addition to
other authorizations of appropriations that are available for
such purpose.
SEC. 302. ADMINISTRATIVE DETENTION.
(a) Expanded Authority.--Section 304 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding
at the end the following subsection:
"(h) Administrative Detention of Foods.--
"(1) Detention authority.--
"(A) In general.--An officer or qualified employee of the
Food and Drug Administration may order the detention, in
accordance with this subsection, of any article of food that
is found during an inspection, examination, or 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 section 302. The Secretary
shall by regulation provide for procedures for instituting
such action on an expedited basis with respect to perishable
foods.
"(3) Security of detained article.--An order under
paragraph (1) with respect to an article of food may require
that such article be labeled or marked as detained, and may
require that the article be removed to a secure facility. An
article subject to such an order shall not be transferred by
any person from the place at which the article is ordered
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.
"(4) Appeal of detention order.--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 72 hours after such
an appeal is filed, the Secretary, after providing
opportunity for an informal hearing, shall confirm or
terminate the order involved, and such confirmation by the
Secretary shall be considered a final agency action for
purposes of section 702 of
[[Page H9206]]
title 5, United States Code. If during such 72-hour period
the Secretary fails to provide such an opportunity, or to
confirm or terminate such order, the order is deemed to be
terminated.".
(b) Prohibited Act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331) is 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
301(c) of this Act, is amended by adding at the end the
following:
"(j)(1) If an officer or qualified employee of the Food
and Drug Administration has credible evidence or 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.
"(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.".
SEC. 303. PERMISSIVE DEBARMENT REGARDING FOOD IMPORTATION.
(a) In General.--Section 306(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a(b)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by striking "or" after the comma
at the end;
(B) in subparagraph (B), by striking the period at the end
and inserting ", or"; and
(C) by adding at the end the following subparagraph:
"(C) a person from importing an article of food or
offering such an article for import into the United
States.";
(2) in paragraph (2), in the matter preceding subparagraph
(A), by inserting "subparagraph (A) or (B) of" before
"paragraph (1)";
(3) by redesignating paragraph (3) as paragraph (4); and
(4) 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
article of food; or
"(B)(i) the person has repeatedly imported or offered for
import adulterated articles of food; and
"(ii) the person knew, or should have known, that such
articles were adulterated.".
(b) Conforming Amendments.--Section 306 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is amended--
(1) in subsection (a), in the heading for the subsection,
by striking "Mandatory 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"; and
(C) in subparagraph (B), in each of clauses (i) and (ii),
by inserting "or subsection (b)(3)" after "subsection
(b)(2)(B).
(c) Effective Dates.--Section 306(l)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) is
amended--
(1) in the first sentence--
(A) by striking "and" after "subsection (b)(2)"; and
(B) by inserting ", and subsection (b)(3)" after
"subsection (b)(2)(B)"; and
(2) in the second sentence, by inserting ", subsection
(b)(3)," after "subsection (b)(2)(B)".
(d) Prohibited Act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act, as amended by section 302(b) of this Act,
is amended by adding at the end the following:
"(cc) The importing or offering for import into the United
States of an article of food by, with the assistance of, or
at the direction of, a person debarred under section
306(b)(1)(C).".
SEC. 304. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.
(a) In General.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at
the end the following section:
"SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.
"(a) Records Inspection.--If the Secretary has credible
evidence or information indicating that an article of food
presents a threat of serious adverse health 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 investigating such credible evidence or
information. 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 maintenance of records by persons
(excluding farms and restaurants) who manufacture, process,
pack, transport, distribute, receive, hold, or import food,
as may be necessary to trace the source and chain of
distribution of food and its packaging in order to address
credible threats of serious adverse health consequences or
death to humans or animals. The Secretary shall take into
account the size of a business in promulgating regulations
under this 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 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
credible evidence or information indicating that an article
of food 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(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(e)) is amended--
(1) by striking "by section 412, 504, or 703" and
inserting "by section 412, 414, 504, 703, or 704(a); and
(2) by striking "under section 412" and inserting "under
section 412, 414(b)".
SEC. 305. REGISTRATION.
(a) In General.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.), as amended by section
304 of this Act, is amended by adding at the end the
following:
"SEC. 415. REGISTRATION.
"(a) Registration.--
[[Page H9207]]
"(1) In general.--Any facility (excluding farms) engaged
in manufacturing, processing, packing, or holding food for
consumption in the United States shall be registered with the
Secretary. To be registered--
"(A) for a domestic facility, the owner, 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 identity 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, or successor 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 other information required to be
submitted under this subsection shall not be subject to the
disclosure requirements of section 552 of title 5, United
States Code.
"(b) Exemption.--The Secretary shall by regulation exempt
types of retail establishments from the requirements of
subsection (a) only if the Secretary determines that the
registration of such facilities is not needed for effective
enforcement of this chapter and any regulations issued under
this chapter.
"(c) Facility.--For purposes of this section, the term
`facility' includes any factory, warehouse, or establishment
(including a factory, warehouse, or establishment of an
importer), that manufactures, processes, packs, or holds
food. Such term does not include restaurants or other
establishments in which food is served solely for immediate
human consumption.
"(d) 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.--
(1) In general.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by section 303(d) of
this Act, is amended by adding at the end the following:
"(dd) The failure to register in accordance with section
415.".
(2) Misbranded food.--Section 403 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding
at the end the following:
"(t) If it is manufactured, processed, packed, or held in
a facility that is not registered in accordance with section
415.".
(c) Effective Date.--The amendment made by subsection (b)
shall take effect 180 days after the date of the enactment of
this Act.
(d) Notice.--Not later than 60 days after the date of the
enactment of this Act, the Secretary of Health and Human
Services, after consultation with appropriate State and local
officials, shall take sufficient measures to notify entities
that manufacture, process, pack, or hold food for consumption
in the United States of the requirement pursuant to this
section that facilities be registered with the Secretary. The
Secretary shall develop guidance, as needed, to identify
facilities required to register under this section.
(e) 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.
(f) Savings Clause.--This section may not be construed as
authorizing the Secretary of Health and Human Services to
impose any requirements with respect to a food to the extent
that it is within the exclusive jurisdiction of the Secretary
of Agriculture pursuant to the Federal Meat Inspection Act
(21 U.S.C. 601 et seq.), the Poultry Products Inspection Act
(21 U.S.C. 451 et seq.), or the Egg Products Inspection Act
(21 U.S.C. 1031 et seq).
SEC. 306. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 302(c) of this Act, is
amended by adding at the end the following subsection:
"(k)(1) In the case of an article of food that is being
imported or offered for import into the United States, the
Secretary, after consultation with the Secretary of the
Treasury, shall by regulation require, for the purpose of
enabling such article to be inspected at ports of entry into
the United States, the submission to the Secretary of a
notice providing the identity of each of the following: The
article; the manufacturer and shipper of the article, and if
known within the specified period of time that notice is
required to be provided, the grower of the article; the
country from which the article originates; the country from
which the article is shipped; and the anticipated port of
entry for the article. An article of food imported or offered
for import without submission of such notice in accordance
with regulations under this paragraph shall be refused
admission into the United States. Nothing in this section may
be construed as a limitation on the port of entry for an
article of food.
"(2)(A) Regulations under paragraph (1) shall require that
a notice under such paragraph be provided by a specified
period of time, not fewer than 24 hours, in advance of the
time of the importation of the article of food involved or
the offering of the food for import, except that the advance
period so required may not exceed 72 hours.
"(B)(i) If an article of food is being imported or offered
for import into the United States and a notice under
paragraph (1) is not provided in advance in accordance with
subparagraph (A), such article shall be held at the port of
entry for the article, and may not be delivered to the
importer, owner, or consignee of the article, until such
notice is submitted to the Secretary, and the Secretary
examines the notice and determines that the notice is in
accordance with regulations under paragraph (1). The
preceding sentence may not be construed as authorizing such
delivery pursuant to the execution of a bond, pending such a
determination by the Secretary.
"(ii) In carrying out clause (i) with respect to an
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)(1) of this
Act, is amended by adding at the end the following:
"(ee) The importing or offering for import into the United
States of an article of food in violation of regulations
under section 801(k).".
SEC. 307. AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO
UNITED STATES.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)), as amended by section 306(a)
of this Act, is amended by adding at the end the following:
"(l)(1) If a food has been refused admission under
subsection (a), other than such a food that is required to be
destroyed, and the Secretary determines that the food
presents a threat of serious adverse health consequences or
death to humans or animals, the Secretary may require the
owner or consignee of the food to affix to the container of
the food a label that clearly and conspicuously bears the
statement: `UNITED STATES: REFUSED ENTRY'.
"(2) All expenses in connection with affixing a label
under paragraph (1) shall be paid by the owner or 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), as amended by section
305(b)(2) of this Act, is amended by adding at the end the
following:
"(u) If it fails to bear a label required by the Secretary
under section 801(l)(1) (relating to food refused admission
into the United States).".
(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.
SEC. 308. PROHIBITION AGAINST PORT SHOPPING FOR IMPORTATION.
Section 402 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 342) is amended by adding at the end the following:
"(h) If it is an article of food imported or offered for
import into the United States and such article has 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 is not adulterated, as determined by the
Secretary.".
SEC. 309. NOTICES TO STATES REGARDING IMPORTED FOOD.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 391 et seq.) is amended by adding at the end the
following new section:
[[Page H9208]]
"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 the notice to a
State, the Secretary shall request the State to take such
action as the State considers appropriate, if any, to protect
the public health regarding the food involved.
"(b) Rule of Construction.--Subsection (a) may not be
construed as limiting the authority of the Secretary with
respect to adulterated food under any other provision of this
Act.".
SEC. 310. GRANTS TO STATES FOR INSPECTIONS; RESPONSE TO
NOTICE REGARDING ADULTERATED IMPORTED FOOD.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 391 et seq.), as amended by section 309 of this Act,
is amended by adding at the end the following new section:
"SEC. 909. GRANTS TO STATES REGARDING FOOD INSPECTIONS.
"(a) In General.--The Secretary may make grants to States
and Territories for the purpose of conducting with respect to
food examinations, inspections, investigations, and related
activities under section 702 through individuals who, under
subsection (a) of such section, are duly commissioned by the
Secretary as officers of the Department.
"(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 notices
under section 908, including planning and otherwise preparing
to take such action.
"(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2006.".
Subtitle B--Protection of Drug Supply
SEC. 311. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS;
SHIPPING INFORMATION; DRUG AND DEVICE LISTING.
(a) Annual Registration; Listing.--
(1) In general.--Section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360) is amended--
(A) in subsection (i)(1)--
(i) by striking "Any establishment" and inserting "On or
before December 31 of each year, any establishment";
(ii) by striking "establishment and the name" and
inserting "establishment, the name"; and
(iii) by inserting before the period the following: ", the
name of each importer of such drug or device in the United
States that is known to the establishment, and the name of
each carrier used by the establishment in transporting such
drug or device to the United States for purposes of
importation"; and
(B) in subsection (j)(1), in the first sentence, by
striking "or (d)" and inserting "(d), or (i)".
(2) Misbranding.--Section 502(o) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(o)) is amended by striking
"in any State".
(b) Importation; Statement Regarding Registration of
Manufacturer.--
(1) In general.--Section 801 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 307(a) of this Act, is
amended by adding at the end the following subsection:
"(m) A drug or device that is imported or offered for
import into the United States may be refused admission if the
importer of the drug or device does not, at the time of
offering the drug or device for import, submit to the
Secretary a statement that identifies the registration under
section 510(i) of each establishment that with respect to
such drug or device is required under such section to
register with the Secretary.".
(2) Prohibited act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act, as amended by section 306(b) of this Act,
is amended by adding at the end the following:
"(ff) The importing or offering for import into the United
States of a drug or device with respect to which there is a
failure to comply with an order of the Secretary to submit to
the Secretary a statement under section 801(m).".
(c) Effective Date.--The amendments made by this section
take effect upon the expiration of the 180-day period
beginning on the date of the enactment of this Act.
SEC. 312. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING
IMPORT COMPONENTS INTENDED FOR USE IN EXPORT
PRODUCTS.
(a) In General.--Section 801(d)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to
read as follows:
"(3)(A) Subject to subparagraph (B), no component of a
drug, no component part or accessory of a device, or other
article of device requiring further processing, which is
ready or suitable for use for health-related purposes, and no
article of a food additive, color additive, or dietary
supplement, including a product in bulk form, shall be
excluded from importation into the United States under
subsection (a) if each of the following conditions is met:
"(i) The importer of such article of a drug or device or
importer of such article of a food additive, color additive,
or dietary supplement submits to the Secretary, at the time
of initial importation, a statement in accordance with the
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, carrier, or
other entity that had possession of the article in the chain
of possession of the article from the manufacturer to such
importer of the article.
"(ii) If such article is known to be, or to contain or
bear, any chemical substance or biological substance, the
statement under clause (i) is accompanied by such
certificates of analysis as are necessary to identify each
such substance.
"(iii) 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.
"(iv) 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.
"(v) The initial owner or consignee maintains records on
the use or destruction of such article or portions thereof,
as the case may be, and submits to the Secretary any such
records requested by the Secretary.
"(vi) Upon request of the Secretary, the initial owner or
consignee submits a report that provides an accounting of the
exportation or destruction of such article or portions
thereof, and the manner in which such owner or consignee
complied with the requirements of this subparagraph.
"(B) Subparagraph (A) does not apply to the import or
offering for import into the United States of an article if
the Secretary determines that there is credible evidence or
information indicating that such article presents a threat of
serious adverse health consequences or death to humans or
animals.
"(C) This section may not be construed as affecting the
responsibility of the Secretary to ensure that articles
imported into the United States under authority of
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.
TITLE IV-DRINKING WATER SECURITY AND SAFETY
SEC. 401. AMENDMENT OF THE SAFE DRINKING WATER ACT.
The Safe Drinking Water Act (title XIV of the Public Health
Service Act) is amended as follows:
(1) By inserting the following new sections after section
1432:
"SEC. 1433. TERRORIST AND OTHER INTENTIONAL ACTS.
"(a) Vulnerability Assessments.--(1) Each community water
system serving a population of greater than 3,300 persons
shall conduct an assessment of the 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 March 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
[[Page H9209]]
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) prior
to:
"(A) December 31, 2002, in the case of systems serving a
population of 100,000 or more.
"(B) June 30, 2003, in the case of systems serving a
population of 50,000 or more but less than 100,000.
"(C) December 31, 2003, in the case of systems serving a
population greater than 3,300 but less than 50,000.
"(b) Emergency Response Plan.--Each 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) 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 or
drinking water provided to communities and individuals.
"(d) Funding.--There are authorized to be appropriated to
carry out this section not more than $120,000,000 for the
fiscal year 2002 and such sums as may be necessary for fiscal
year 2003 and fiscal year 2004. The Administrator, in
coordination with State and local governments, may provide
financial assistance to community water systems for purposes
of compliance with the requirements of subsections (a) and
(b) and to 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 under subsection (a).
"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 designed to monitor and
detect chemical, biological, and radiological contaminants
and reduce the likelihood that such contaminants can be
successfully introduced into water supplies intended to be
used for drinking water.
"(2) Methods and means to provide sufficient notice to
operators of public water systems, and 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) Procedures and equipment necessary to prevent the
flow of contaminated drinking water to individuals served by
public water systems.
"(4) Methods, means, and equipment which could negate or
mitigate deleterious effects on public 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.
"(5) Biomedical research into the short-term and long-term
impact on public health of various chemical, biological and
radiological contaminants that may be introduced into public
water systems through terrorist of other intentional acts.
"(b) Funding.--For the authorization of appropriations to
carry out this section, see section 1435(c).
"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.
"(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) 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 fiscal year 2003 and fiscal year 2004.".
(2) Section 1414(i)(1) is amended by inserting "1433"
after "1417".
(3) Section 1431 is amended by inserting in the first
sentence after "drinking water" the following: ", or that
there is a threatened or potential terrorist attack (or other
intentional act designed to disrupt the provision of safe
drinking water or to impact adversely the safety of drinking
water supplied to communities and individuals), which".
(4) 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".
(5) Section 1442 is amended as follows:
(A) By striking "this subparagraph" in subsection (b) and
inserting "this subsection".
(B) By amending subsection (d) to read as follows:
"(d) There are authorized to be appropriated to carry out
subsection (b) not more than $35,000,000 for the fiscal year
2002 and such sums as may be necessary for each fiscal year
thereafter.".
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Louisiana (Mr. Tauzin) and the gentleman from Michigan (Mr. Dingell)
each will control 20 minutes.
The Chair recognizes the gentleman from Louisiana (Mr. Tauzin).
General Leave
Mr. TAUZIN. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days within which to revise and extend their remarks
and to insert extraneous material on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Louisiana?
There was no objection.
Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in strong support of the Public Health Security
and Bio-terrorism Response Act of 2001 which I have introduced with my
good friend, the gentleman from Michigan (Mr. Dingell) the ranking
member of the Committee on Energy and Commerce and a strong bipartisan
list of co-sponsors. This may be the last piece of legislation we
consider tonight, Mr. Speaker,
[[Page H9210]]
but it is, by far, the most serious one and the most important one,
and we will be asking for a recorded vote tomorrow on this important
legislation.
The legislation is all about safety and security of American families
and of our country. Today we are stepping up to the profound threats of
terrorism and other public health emergencies. And we do so by
combining smart and innovative policy with additional resources to
prepare the country for bioterrorist threats and to improve our
abilities to respond quickly and effectively to such threats when they
arise.
Mr. Speaker, let me be very specific about the important investments
that this legislation will make and the dramatic range of issues it
will address.
First, Title I of the bill significantly steps up our preparedness
and our capacity to identify and respond to threats. This Title will
improve communications between and among the levels of government,
public health officials, the first responders and health care providers
and the health care facilities during emergencies.
Our bill authorizes $1 billion in FY 2002 in grants to States, local
governments, and other public and private health care facilities and
other entities to improve planning and preparedness activities, to
enhance laboratory capacity, and to educate and train the health
personnel that will take care of folks who are subject to any kinds of
such threats.
We specifically authorized $40 million in FY 2002 for training grants
to relieve shortages in critical health care professions. The
Department of Health and Human Services will have a new focus, an
improved coordination and accountability through a new assistant
secretary of emergency preparedness. The legislation also authorizes
the national disaster medical system, new planning and reporting
provision, health professional verification systems during emergencies,
the training exercises, and improved communication strategies. The bill
further authorizes $450 million in FY 2002 for the Centers for Disease
Control and Prevention to upgrade its capacity to deal with public
health threats, to renovate its facilities and to improve its
securities.
H.R. 3448 will also ensure that we have sufficient drugs, vaccines
and other supplies for our Nation's health security. Title I, for
example, authorizes more than $1.1 billion for the Secretary of Health
and Human Services to expand our current National stockpiles of
medicines and other supplies, including the purchase of smallpox
vaccines, will encourage and expand research and develop of drugs of
vaccines and devices to combat bioterrorism and other potential disease
outbreaks in our country. The bill also will enhance controls on deadly
biological agents in order to help prevent bioterrorism and establish a
national database of dangerous pathogens.
Title II imposes new registration requirements on all possessors of
the 36 most dangerous biological agents and toxins. It mandates tough
new safety and security requirements to ensure that only legitimate
scientists working in appropriate laboratory facilities can gain access
to these potential weapons of mass destruction.
Title II also enhances criminal penalties for those caught in
possession of those agents or transferring them without proper
registration. And Title III of the bill will help protect American
safety in their food and drug supplies. We are increasing by $100
million the Food and Drug Administration's resources to hire more
inspectors at the border, to develop new methods to detect contaminated
foods. In addition, we are providing the Secretary the additional
regulatory authority he requested for the FDA to detain food and to
investigate credible evidence of contamination and improve access to
records and recordkeeping to assist the Secretary in investigating any
threats to our food supply. This title also improves our enforcement
and inspection capabilities for those drug supplies. The new resources
and authorities will substantially improve our country's ability to
ensure the safety confidence in both our food and our drug supplies.
{time} 2230
Title 4 of the legislation will ensure that drinking water systems
across the country assess their vulnerability to terrorist attack and
develop emergency plans to prepare for and respond to those attacks.
This title also requires a comprehensive review of the ways to detect
and respond to chemical, biological, and radiological contamination of
drinking water, as well as way to prevent and mitigate the effects of
physical attacks. In addition, existing criminal penalties and fines
for tampering with drinking water systems are substantially increased.
A total of $170 million in fiscal year 2002 is authorized for these
important efforts.
Americans deserve to know that we are taking concerted action today
to protect the water they drink every single day. Title IV will lay the
groundwork for developing the necessary information, and emergency
planning and response efforts that are needed to address this new
threat.
Mr. Speaker, this legislation builds on the tremendous work and
leadership of our President, President Bush, and his administration,
over the last 3 months. Importantly, it builds on existing programs
rather than creating new ones that will only delay the distribution of
monies to the front lines. We have spent time to integrate programs and
to make sure our national efforts are focused and better coordinated.
We have worked closely with the administration to achieve this result,
and I am frankly very confident the President will sign this bill.
I want to thank the gentleman from Michigan (Mr. Dingell) and the
other members of the committee on both sides of the aisle for their
tireless and extraordinarily good-faith efforts to produce a great
bill. This is remarkable legislation, Mr. Speaker, for remarkable
times. The House can be very proud not only of this product but also of
a country that is responding in such a unified way as exemplified by
the bipartisan spirit in which we bring this legislation to the floor.
America, I think, will be proud of our commitment made in this bill
to the right investments and the smart policy choices to meet the
challenges and protect our Nation's public health. I urge all my
colleagues to support this very landmark legislation.
Mr. Speaker, I submit for the Record letters to and from the Chairman
of the Committee on Science and myself regarding this legislation.
House of Representatives,
Committee on Energy and Commerce,
Washington, DC, December 11, 2001.
Hon. Sherwood L. Boehlert,
Chairman, Committee on Science, House of Representatives,
Rayburn House Office Building, Washington, DC.
Dear Chairman Boehlert: Thank you for your letter regarding
H.R. ____, the Public Health Security and Bioterrorism
Response Act of 2001.
I appreciate your willingness not to seek a referral of the
bill. I agree that your decision to forgo action on the bill
will not prejudice the Committee on Science with respect to
its jurisdictional prerogatives on this or similar
legislation. Further, I recognize your right to request
conferees on those provisions within the Committee on
Science's jurisdiction should they be the subject of a House-
Senate conference.
I will include your letter and this response in the
Congressional Record when the bill is considered on the
Floor.
Sincerely,
W.J. "Billy" Tauzin,
Chairman.
____
House of Representatives,
Committee on Science,
Washington, DC, December 11, 2001.
Hon. W.J. Tauzin,
Chairman, Committee on Energy and Commerce, Rayburn HOB,
Washington, DC.
Dear Mr. Chairman: Earlier today you and your colleagues
introduced the "Public Health Security and Bioterrorism
Response Act of 2001." Knowing of your interest in moving
the legislation through the House as quickly as possible, I
am prepared not to seek a sequential referral of the bill's
provisions that affect the jurisdiction of the Science
Committee. Despite waiving the right to seek a referral, the
Science Committee does not waive its jurisdiction over the
bill. Additionally, the Science Committee expressly reserves
its authority to seek conferees on any provisions that are
within its jurisdiction during any House-Senate conference
that may be convened on this legislation or like provisions
in the bill or similar legislation which falls within the
Science Committee's jurisdiction. I ask for your commitment
to support any request by the Science Committee for conferees
on the bill, as well as any similar or related legislation.
Based on a quick review, here are some of the provisions I
believe affect the Science Committee's jurisdiction:
Section 108 (Working Group on Preparedness). New
subsections (a)(1)-(3) require a joint working group,
including DOE and EPA, to coordinate and prioritize research,
[[Page H9211]]
facilitate the development of countermeasures, and coordinate
research and development.
Section 108 (Working Group on Preparedness). New subsection
(a)(4) requires the Working Group, including DOE and EPA, to
develop shared standards for equipment.
Section 126 (Evaluation of New and Emerging Technologies).
Subsection (b) requires the Secretary of HHS to survey
existing technology programs funded by the Federal Government
for potentially useful technologies and, in consultation with
an interagency working group that includes DOE and EPA, to
evaluate technologies.
Section 137 (Expanded Research by Secretary of Energy).
This authorizes DOE research related to bioterrorist attacks.
Section 401 (Drinking Water Security and Safety). This
reauthorizes an existing environmental research and
development program in the Safe Drinking Water Act. Section
401 also authorizes two new programs, in proposed sections
1434 and 1435 of the SDWA, that direct EPA to "review
current and future methods and means" relating to
contamination and physical disruption of water systems. These
provisions are similar to provisions in the Science
Committee's bill, H.R. 3178.
H.R. 3178 passed the Science Committee on November 15. It
authorizes EPA research related activities to develop anti-
terrorism tools for water and wastewater agencies. Since our
markup of H.R. 3178, my staff has worked with your staff to
clarify the text of H.R. 3178 to prevent or reduce any
jurisdictional issues. I look forward to the continued
cooperation between our two Committees on both H.R. 3178 and
the "Public Health Security and Bioterrorism Response Act of
2001."
I request that you include this exchange of letters in the
Congressional Record as part of the Floor debate on the bill.
Thank you again for your consideration and attention
regarding these matters.
Sincerely,
Sherwood Boehlert,
Chairman.
Mr. Speaker, I reserve the balance of my time.
Mr. DINGELL. Mr. Speaker, I yield myself 3 minutes.
(Mr. Dingell asked and was given permission to revise and extend his
remarks.)
Mr. DINGELL. Mr. Speaker, today we are considering bipartisan
legislation on a matter of utmost national importance, our preparedness
against terrorism. I want to begin by commending my good friend, the
chairman of the committee, the gentleman from Louisiana (Mr. Tauzin),
the gentleman from Florida (Mr. Bilirakis), and the gentleman from Iowa
(Mr. Ganske), as well as my colleagues, the gentleman from Ohio (Mr.
Brown), the gentleman from New Jersey (Mr. Menendez), and the gentleman
from New Jersey (Mr. Pallone), the gentleman from Florida (Mr.
Deutsch), who worked so hard on this, and the gentlewoman from
California (Ms. Harman).
This bill was put together in the best bipartisan traditions of the
way the Committee on Energy and Commerce has always worked, and it
resolves in the best possible way the questions that concern us with
regard to preparedness and protection of our people against
bioterrorism.
There are many excellent provisions in the legislation, including
improvement and protection of drinking water supply, tighter controls
on dangerous biological agents, and a number of other things, including
putting support where it needs to be put to help our people to address
the problems which they have on the local level and to improve Federal-
local cooperation in these matters. It also does something very
important, and that is it improves inspection resources for imported
food.
These are only a downpayment on what will ultimately be necessary,
but nonetheless they are an enormous increase over the way things are
done at this particular time.
Mr. Speaker, I urge my colleagues, without exception, to support it.
It is bipartisan, it is good, it is in the public interest; and I again
commend my colleagues, including our chairman, for the fine work which
has been done on this very difficult and very important piece of
legislation.
In addition, Mr. Speaker, I include for the Record a detailed
explanation of the bill:
Title III, Subtitle A--Protection of Food Supply, addresses
existing deficiencies in the Nation's food safety
infrastructure and takes appropriate steps to protect the
Nation's food supply from new threats of terrorism. In
particular, it authorizes new powers and $100 million to the
Food and Drug Administration (FDA) so it can increase and
improve inspections of imported food at the 307 different
U.S. ports of entry. With the additional funds and
authorities in this bill, FDA should be equipped to inspect
about 2 percent of all imported food shipments. While this
remains significantly less than FDA's recommendation to
inspect 10 percent of all imported food shipments, this
legislation is an important downpayment.
The subtitle also provides for permissive debarment of
scofflaw food importers, requires prior notice of shipments,
provides administrative detention authority, requires
registration and recordkeeping, and bars port shopping.
Vigorous and targeted use of these new authorities should
enable the Secretary to mitigate problems caused by too few
inspectors.
For example, under this subtitle the Secretary must possess
credible evidence or information indicating that a specific
shipment or article of food presents a serious health threat
to exercise his full detention authority. However, the bill
establishes a broader, less-stringent standard for the
Secretary to exercise a more limited temporary hold
authority. Under the temporary hold provision, the Secretary
need only have credible evidence or information indicating
that an article of food, not a specific article of food,
presents a serious health threat. If, for example, the FDA is
in possession of credible evidence or information indicating
that a category of food or food from a certain geographical
region presents such a threat, the Secretary may use this
authority to temporarily hold shipments or articles of food
(up to 24 hours) based on that information. This will enable
the Secretary to appropriately dispatch FDA resources to
gather credible evidence or information (based upon FDA
inspection, examination or investigation) about specific
shipments or articles of food. Once FDA has such evidence or
information, the Secretary may then detain any such shipments
or articles of food under the detention authority (up to 30
days). The temporary hold authority is intended to function
as an investigative tool that enables FDA to use its
detention authority, and its resources, more effectively.
Accordingly, the circumstances under which temporary hold
authority can be invoked are broader than those under which
detention authority can be invoked.
Title III, Subtitle B--Protection of Drug Supply, includes
Section 312, which requires additional information regarding
import components intended for use in export products. This
section does not change any definitions of regulated articles
or the scope of regulation of those articles as set forth in
the Federal Food, Drug, and Cosmetic Act (FFDCA) and its
implementing regulations. Further, it is not the intent
of this section for the Secretary of Treasury to engage in
a new rulemaking to determine the requirement for bonds
for goods imported under section 801(d)(3) of the FFDCA.
Existing requirements for the bonding of goods imported
for further processing and export should be applied.
Finally, certificates of analysis are not required if the
only chemical or biological component of the good imported
under 801(d)(3) is de minimus, incidental, and poses no
danger to human or animal health.
Title IV--Drinking Water Security and Safety, adds a new
section 1433 to the Safe Drinking Water Act that requires
community water systems to conduct assessments of the
vulnerability of its system to a terrorist attack. Sandia
National Laboratories, under a contract with the
Environmental Protection Agency (EPA), has developed a new
methodology for assessing and improving the security of
drinking water systems. Under Section 1433 vulnerability
assessments should include comprehensive site
characterizations, a determination of the consequences of
intentional acts or terrorist attacks, and an analysis of the
use, storage, or handling of various chemicals to see whether
a substitution to less dangerous chemicals will enhance the
safety and health of the public in the case of an attack. For
example, many drinking water systems are switching away from
liquid chlorine to other chemicals that minimize the risk of
an airborne toxic plume in case of a tank explosion. Further,
the term "physical barriers" should be interpreted to
include "buffer zones" to a physical attack.
Section 1433 also requires that emergency response plans be
prepared or revised by community water systems after the
vulnerability assessments. In FY 2002, the bill authorizes
$120 million to assist water systems in conducting
vulnerability assessments and preparing emergency response
plans. This funding is available to also provide financial
assistance to water systems for basic security enhancements
and to address significant threats to public health. Basic
security enhancements of critical importance include
management systems, operating procedures, re-keying locks,
buffer zones, cameras, fencing, hardening of storage tanks,
equipment for back flow monitoring, security screening of
contractor support services, and intrusion alert systems.
The bill charges the EPA, working with other agencies such
as CDC and the FBI, to provide water systems with a
consistent definition of the range of threats facing a
system. This will help ensure that quality vulnerability
assessments are conducted.
Title IV also contains amendments to Section 1432 of the
Safe Drinking Water Act to increase the criminal penalties
for tampering or threatening to tamper with a public drinking
water system.
Finally, the bill amends Section 1431 of the Safe Drinking
Water Act to provide new authority to the Administrator to
take actions to assure the safety of the public and protect
supplies of drinking water in circumstances
[[Page H9212]]
of a threatened or potential terrorist attack at a community
water system which may present an imminent and substantial
endangerment to the health of persons.
The term "potential terrorist attack" should be
interpreted in the context of the President's announcements
that the United States is engaged in a war against terrorism
and faces "continuing and immediate threats of further
attacks." Senior government officials have repeatedly warned
that critical infrastructure facilities should remain on a
high state of alert due to the possibility of a terrorist
attack. Critical infrastructure protection is an issue of
importance to economic and national security. Presidential
Decision Directive 63 released in May 1998 identified water
supply as one of the 12 areas critical to the functioning of
the country.
The Government has a responsibility to protect our
citizens, and that responsibility begins with homeland
security. Where the Administrator receives information that
critical community water system infrastructures, such as a
utility pumping system or chemical storage tanks, are
vulnerable to potential terrorist attack that may present an
imminent and substantial endangerment he or she may use the
authority provided by Section 1431 to protect the health and
safety of the public or prevent the disruption of drinking
water supplies.
Mr. Speaker, I reserve the balance of my time.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 3 minutes to the
gentleman from Florida (Mr. Bilirakis), the chairman of the
Subcommittee on Health of the Committee on Energy and Commerce.
Mr. BILIRAKIS. Mr. Speaker, I thank the gentleman for yielding me
this time, and I too rise in support of this bill.
As we know, today is the 3-month anniversary of the worst terrorist
attack on American soil in history. Our thoughts and prayers are with
the victims and their families today and every day. I share the
concerns, we all share the concerns of all Americans who are worried
about future terrorist activities, including bioterrorist attacks. With
the recent anthrax outbreak, bioterrorism of course has become a
reality.
Bioterrorism is an issue that has been explored by the Committee on
Energy and Commerce and my Subcommittee on Health for several years.
Because we cannot know when or how a public health threat might occur,
we must be prepared to combat any biological agent in any form. I am
pleased that we were able to work on a bipartisan, underline
bipartisan, basis to craft this reasonable and responsible legislative
package.
State and local governments will be the first to respond to a
bioterrorist attack. This legislation requires the Secretary of Health
and Human Services to work with local governments to develop
bioterrorist preparedness plans. This legislation requires the CDC to
enhance training of personnel, improve their communications network and
intensify security to protect important research and dangerous
pathogens.
Since health care providers will be the first to respond to a public
health emergency, it is essential that we have health professionals
ready to deal with health care needs in the event of a bioterrorist
attack. This legislation begins to address shortages in areas such as
medical technologists and pharmacists by providing grants to train and
educate individuals in areas of the greatest need.
As vice chairman of the House Committee on Veterans' Affairs, I also
believe it is essential that we fully utilize all of our Federal
resources in our fight against bioterrorism. This legislation requires
the Department of Health and Human Services to work with the Department
of Veterans Affairs and the Department of Defense in developing our
national response. These agencies have significant resources and
expertise and are crucial to our efforts.
In addition, this legislation increases the protection of the
Nation's food supply. In the past, too few resources have been
dedicated to food security, and this legislation is a great
improvement. Secretary of Health and Human Services Tommy Thompson
recently testified before the committee that the Food and Drug
Administration must increase the number of inspectors at the borders.
I would like in closing, Mr. Speaker, to thank the staff, who
dedicated many long hours to developing this legislation. For the
majority, that includes Nandan Kenkeremath, Tom DiLenge, Amit Sachdev,
Brent DelMonte, Bob Meyers, and Pat Morrisey. From the minority, that
includes John Ford, Edith Holleman, and Bruce Gwinn. And I would also
like to extend a special thank you to legislative counsel Pete Goodloe,
who was instrumental in drafting this legislation. All of the staff,
all of them, spent countless hours, especially over the Thanksgiving
holiday, to prepare this vital legislation.
I too urge our colleagues to join us in supporting this bill. It is
important that we act this year to increase our readiness and our
safety.
Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the gentleman from
Ohio (Mr. Brown).
Mr. BROWN of Ohio. Mr. Speaker, I thank the gentleman for yielding me
this time; and I am pleased to join my colleagues, the gentleman from
Michigan (Mr. Dingell), the gentleman from Louisiana (Mr. Tauzin), the
gentleman from Florida (Mr. Bilirakis), the gentleman from New Jersey
(Mr. Pallone), and the gentleman from Florida (Mr. Deutsch), in
offering this bipartisan bioterrorism preparedness bill.
I want to thank the Committee on Energy and Commerce staff, who
worked so hard on this bill, as mentioned by the gentleman from Florida
(Mr. Bilirakis), including Ann Esposito, John Ford, Dave Nelson, Edith
Holleman, and Bruce Gwinn. Also, legislative counsel Pete Goodloe, who
worked so very hard on all of this.
The events of September 11 and the recent spate of anthrax attacks
have significantly underscored the importance, to be sure, of our
Nation's public health infrastructure. We need to pay far more
attention to the first responders to a public health emergency, to the
key health agencies charged with addressing and preventing these
emergencies, and to the safeguards needed to minimize threats in the
future.
We must have sufficient antibiotic and vaccine stockpiles, we must
have the ability to rapidly distribute medical supplies and deploy
medical personnel, and we must cultivate the expertise and technology
necessary to identify and eliminate threats before they become public
health crises.
This bill was written to provide new authority to Food and Drug
Administration border inspectors in terms of food safety, to require
the development of rapid testing techniques, and to authorize $100
million of new found for all of FDA's border inspection activities.
These provisions will increase FDA's presence at the border and allow
for the inspection of a greater percentage of our imported foods,
making our food supplies safer from bioterrorists.
Eight years ago, before budget cuts in this Congress, 8 percent of
food was inspected at the border. Today, it is about one-tenth of that.
It is less than 1 percent. The safety of imported foods and the need
for greater enhanced inspection resources at the border have long been
a concern of many of us on this side of the aisle, a fact highlighted
by the imported food safety bills I have introduced with the gentleman
from Michigan (Mr. Stupak), the gentleman from New Jersey (Mr.
Pallone), and the gentleman from Michigan (Mr. Dingell), and others
during the past several sessions of Congress.
The food safety provisions of this bill are a good downpayment on
improving our food safety inspection system, but they do not obviate
the need for passage of a more substantial food safety reform like the
one we introduced in October.
I am pleased that a provision to equip State and local health
departments to rapidly identify antibiotic resistant strains of illness
was in fact included in the bill. Because antibiotic resistant microbes
can be difficult to treat, even under normal circumstances, they pose a
significant threat to public health. We know that antibiotic-resistant
strains of anthrax and other agents can, in fact, have been engineered
for the purposes of bioterrorism. A new or unexpected antibiotic-
resistant strain of illness is a red flag. It could signal a
bioterrorist attack. So the sooner we identify it, the sooner we can
deploy the resources needed to treat it.
The ability to monitor antibiotic resistance becomes even more
critical over the longer term. Whether the goal is bioterrorism
preparedness or simply maintaining our ability to combat everyday
illnesses and infectious disease, a major, major function of the
Centers for Disease Control, we simply cannot
[[Page H9213]]
assess the adequacy of our antibiotic supply over time as long as
antibiotic resistance remains a variable.
This bill is not the last word on bioterrorism, but it is a solid
first step; and I am proud to be one of its chief cosponsors.
Mr. TAUZIN. Mr. Speaker, I am proud to yield 2 minutes to the
gentleman from North Carolina (Mr. Burr), the vice chairman of the
Committee on Energy and Commerce and the chairman of the task force
which helped produce this bill.
Mr. BURR of North Carolina. Mr. Speaker, I thank the chairman for
yielding me this time, I also thank the ranking member; but more
importantly, I thank all the members of the Committee on Energy and
Commerce because traditionally we do not get things done as quickly in
the body as we have on this bill.
I want to take this opportunity to personally thank the staff on both
sides of the aisle, many of whom are here tonight, and many who spent
tens, if not hundreds, of hours on this bill, and much of it over the
Thanksgiving break.
Mr. Speaker, 3 months ago, we were attacked in a savage way. Over
these 3 months, we have seen what is good about America; the response
of the American people, in many cases to individuals they did not know.
What we have seen good about this institution is its ability to throw
down the partisanship that sometimes overtakes us and for Democrats and
Republicans to work together on an initiative that America needs today.
We have come a long way in restructuring our public health agencies
in this country. This is only the first step, though. We have a long
way to go to reach a point that communities deserve for us to have in
place. Through this legislation we strengthen our Federal disaster
response efforts by authorizing in law the National Disaster Medical
System.
This legislation provides for the much-needed resources to improve
the Centers for Disease Control, not only the facilities upgrade that
is needed in Atlanta, but also an additional $150 million in the first
year to make sure that the overuse of laboratories, the space needs,
everything that they need to respond to a threat that we clearly do not
fully understand today are in fact in place.
We send money directly to States and to local public health agencies
in order for them to build out their core capacity to deal with
bioterrorism and other public health threats.
Mr. Speaker, in this, we update and strengthen the pharmaceutical
stockpiles, and we establish a core educational curriculum to train
health care professionals for public health emergencies.
I urge all of my colleagues to support this legislation today, but we
cannot quit until the public health network in the U.S. is trained,
equipped, and prepared to handle all responses and all threats in the
future.
Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the gentleman from New
Jersey (Mr. Pallone).
Mr. PALLONE. Mr. Speaker, I come to the House floor also to offer my
support for this crucial piece of legislation; and again I want to
thank our ranking member, the gentleman from Michigan (Mr. Dingell),
and the ranking member of the subcommittee, the gentleman from Ohio
(Mr. Brown), and the gentleman from Florida (Mr. Deutsch), and all the
staff that I see here tonight who worked so hard on this bill, and
stress the importance of the bill.
{time} 2245
When the terrorist attacks against the World Trade Center and the
Pentagon took place on September 11, I know that my constituents in
particular and all Americans were concerned about possible threats from
biological and chemical warfare that might follow. On September 28, the
General Accounting Office published a report that stated, in fact, our
health departments are ill-equipped, that we are vulnerable to
bioterrorism and underfunded on the Federal, State and local level.
Mr. Speaker, I believe that this bill will remedy this problem in a
crucial way. I want to discuss briefly the water security component of
the bill. With the strong leadership of the gentleman from Louisiana
(Mr. Tauzin) and ranking member, the gentleman from Michigan (Mr.
Dingell), we were able to include language requiring large water
systems serving more than 3,300 persons to conduct a vulnerability
assessment and prepare or update emergency response plans within 6
months after the completion of the vulnerability assessment. In the
process of completing this assessment, serious consideration would be
given to the potential consequences of attack.
For example, what would happen if the on-site chlorine tanks are
attacked with explosives? Should safer substitutes for liquid chlorine
be used? What are the health risks to the public if we are faced with
an air-borne toxic chlorine cloud?
These are the types of questions that need to be evaluated and
answered in a vulnerability assessment.
In addition to the assessment, I was pleased that funding was
authorized in the bill to provide for technical assistance grants from
EPA and funding for publicly owned water systems in an emergency
situation. I do not have to explain the importance of protecting the
public from potential disruption of water service or biological-
chemical contamination of drinking water supplies. Water security has
got to be a top priority in any bioterrorism bill that Congress
considers.
On September 12, President Bush made a comment. He said America is
going forward, and as we do so, we must remain keenly aware of the
threats to our country. Those in authority should take appropriate
precautions to protect our citizens. And according to this bill, Mr.
Speaker, the EPA will have that authority that the President referred
to if an assessment is completed and there is sign of significant
vulnerability, it is a relief to know that the EPA, using its emergency
powers, will be able to work with the community water systems to
promptly correct the inadequacies.
I know that the gentleman from Louisiana (Mr. Tauzin) and the
gentleman from Michigan (Mr. Dingell) worked hard to make sure that
this safe drinking water component is in the bill. I think it is very
important that it is in the bill, and I congratulate them and the staff
again for making sure that this is a part of the bioterrorism response.
Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentleman from Iowa
(Mr. Ganske), a distinguished member of our committee.
Mr. GANSKE. Mr. Speaker, I am pleased to support this bill. My
congratulations to the chairman of the committee and to the ranking
member. This is probably one of the more significant public health
pieces of legislation that Congress has done in a long time and we need
to do it. As a physician, I can tell Members this country is not able
to handle an epidemic. There are very few hospitals, if any, in this
country that can handle an epidemic, and that includes Johns Hopkins or
the University of Iowa Hospital.
This bill provides funding to begin to bolster our public health
response to a bioterrorist attack. We need to provide more funds for
medicines and vaccines. We need to bolster the CDC. We need to
facilitate communications between the Federal Government, the State
governments, local governments. Those things are handled in this bill.
There is a lot in this bill that is very necessary and important. The
one thing that was a concern earlier in the discussion on this bill was
whether Members provide block grants or grants back to the States. I
introduced, along with the gentleman from Arkansas (Mr. Berry) a few
weeks ago. We had about a billion dollars for that. We think that is
important because a lot of States are strapped for cash, and they need
some help. That is in this bill as well. I very much appreciate the
efforts of the chairman and the ranking member, the staff, for this
bill.
In essence, the bill that I introduced a couple of weeks ago and this
bill are very similar. This is a bipartisan bill. It is a bicameral
bill. It is my understanding that the administration is in favor of
this bill. This bill should move. I encourage all Members of the House
to vote for the bill, and for the Senate to do the same so we can move
it to the President's desk.
Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the gentleman from
Florida (Mr. Deutsch).
[[Page H9214]]
Mr. DEUTSCH. Mr. Speaker, I join my colleagues in thanking the
chairman of the full committee and the ranking member as well, as well
as our excellent staff on both sides.
This bill is a product of the entire House, and particularly the
Committee on Energy and Commerce can be very proud of. This legislation
very well might go down as the very most important piece of legislation
that this Congress passes in this session. It has not gotten the most
attention at this point in time, and I hope what it tries to prevent
does not get as much attention because in a sense that would mean a
success.
But I highlight some of the issues that we are facing, and really the
world obviously changed, each of our lives changed, America changed on
September 11. This bill is a step towards dealing with some of those
changes. The budgeting that we had in the past, literally in the past
year, in last year's fiscal year, amounted to approximately $100
million towards bioterrorism. This bill now raises that level to
effectively about $3 billion. Obviously, an incredibly dramatic
increase.
I think there have been Members who have expressed a viewpoint, and
in a sense I share it, maybe that number should even be larger. Even
$30 billion, an order of magnitude different than hopefully what we
will appropriate and authorize in this legislation. But as we work
towards that, it is a question whether or not the agencies could even
deal with this large of an increase, but to that other level I am not
sure it would be possible.
Let me focus on one of the areas where this bill is going to have a
very significant effect, and that is the threat of biological terrorism
in the United States. The bill specifically authorizes $450 million for
smallpox vaccine, requires the Secretary to devise a plan for the
distribution of the national stockpile, including the smallpox vaccine.
The Secretary can designate priority countermeasures as fast track
products for FDA approval. It requires the FDA to issue a final rule
allowing for animal studies to prove efficacy of certain vaccines and
drug countermeasures, and the secretary can award grants or contracts
for research to develop new vaccines, treatments or therapies to
counteract bioterrorist agents.
Mr. Speaker, we have shifted the emphasis far greater and far more
than we had in the past, and this is exactly the response we should be
doing. Along with many of my colleagues, I have visited CDC since
September 11. They cry out for the need that this bill specifically is
addressing. Mr. Speaker, I urge my colleagues to support adoption of
the legislation.
Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentlewoman from
New Mexico (Mrs. Wilson).
Mrs. WILSON. Mr. Speaker, I commend the chairman and ranking member
for their work on this bill. Sometimes we do things quickly and quietly
in this House and get important things done; and probably in the last 3
months, this legislation will stand the test of time as one of the most
important pieces of legislation that we do in this House during this
session.
What it is about is protecting Americans from getting sick or dying
from a disease spread intentionally by people who want to destroy us.
It is a very new world, and we have to change the way that we do things
because the world has changed, and be better prepared so we can detect
disease sooner, we can respond sooner and more effectively, and we can
develop new cures for diseases that are now being genetically
engineered by people who have evil intent.
Mr. Speaker, in the last 3 months, we have learned that our
laboratory system is fragile and can be easily overwhelmed by two
relatively small but frightening anthrax attacks here on the East
Coast; and that the Centers for Disease Control are not large enough
and need to be modernized. We need to expand and integrate that
national network of capacity in our laboratories and our research
institutions. We need to invest in research and development to develop
new ways to detect pathogens in the air, in the water, in food, and
detect them quickly without having to wait for someone to get sick
before we act.
We do not have a register of the dangerous pathogens in this country.
We did not know which laboratories have this particular strain of Ames
anthrax. We need to register them, and also have cultures of them so
that we know the DNA of each pathogen that is being used in the United
States for research. This is a very good bill, Mr. Speaker. I am proud
to support it, and I look forward to its prompt passage in this House
and in the United States Senate.
Mr. DINGELL. Mr. Speaker, I reserve the balance of my time.
Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentleman from
Georgia (Mr. Linder), who was the principal sponsor of a separate piece
of legislation to expand and improve upon the capacities of the CDC.
(Mr. Linder asked and was given permission to revise and extend his
remarks.)
Mr. LINDER. Mr. Speaker, this is a remarkable feat to move a piece of
legislation so important so fast and so well done, and I congratulate
the gentlemen. I particularly thank the gentleman from North Carolina
(Mr. Burr) who headed up the task force to ensure that my bill, H.R.
3219, wound up in this bill.
My bill reauthorized the rebuilding of the CDC $300 million for 2
years in a row and multiyear contracting. Let me tell Members about the
CDC. It is a 55-year-old institution, the largest institution of the
Federal Government not located in the metro area here. It is a world
class intellectual community in a third world facility. Many Members
have visited it.
The CDC facility needs to be upgraded, particularly the security
around it. We have dangerous bugs and viruses there that are being
stored three stories above the loading dock. We need to do this. I am
grateful for Members' response, and I am sure that the Senate will
respond equally. The Secretary of HHS is in favor of this bill. It is
not common in my 27 years in public life that we can introduce a bill
on November 1 and have it voted on December 11. I am grateful for this
bill.
Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentleman from New
Jersey (Mr. Smith).
Mr. SMITH of New Jersey. Mr. Speaker, I rise in strong support of
H.R. 3448. As chairman of the Committee on Veterans Affairs, I am
pleased that the legislation recognizes the vital role that the
Department of Veterans Affairs can and should play in helping our
Nation prepare for future biological attacks.
As many Members know, the VA owns and operates the largest integrated
health care network in the world, consisting of 172 medical centers,
over 800 outpatient clinics, and 90 major research programs and are
ideally suited to try to work, in collaboration with other agencies of
government, on trying to respond to one of these terrorist attacks.
I would also point out to Members that the anthrax letters originated
in my district in Trenton and Hamilton Township, New Jersey. And as all
of the different bodies came together, CDC, Department of Health and
the others, the VA stood ready and was able to provide, if it was
necessary, Cipro and other antibiotics, because they are a major
stockpiling of those pharmaceutical assets. I am happy that the
chairman include in section 101(c) a requirement for the Secretary of
Health and Human Services to evaluate the feasibility of using
biomedical research and development capabilities of the VA in
developing a comprehensive national response to bioterrorist attacks.
{time} 2300
Again, the VA is ideally suited for this. I have introduced a number
of bills that would try to further that. I think we really need to make
sure that they have a very prominent seat at the table.
Mr. DINGELL. Mr. Speaker, I yield myself such time as I may consume.
All the Democrats have agreed with me this is a superb piece of
legislation and they have all gone home to bed so that they could vote
on it tomorrow.
Mr. Speaker, I yield back the balance of my time.
Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume.
Let me conclude by thanking my dear friend, the gentleman from
Michigan (Mr. Dingell), for the extraordinary cooperation shown on this
bill. Speakers have said this before, but I want to emphasize this:
this may be
[[Page H9215]]
the most important thing we conclude in terms of important legislation
for our country's sake as we wind down this session before Christmas.
It is our intent to take a vote on this tomorrow and hopefully ask the
other body to move on it very quickly.
Ms. JACKSON-LEE of Texas. Mr. Speaker, I would also like to thank
House Energy and Commerce Committee Chairman Billy Tauzin and Ranking
Member John Dingell for this important bi-partisan legislation, H.R.
3448, so that we can fulfill our promise to the American people in
terms of preparedness against bioterrorism.
For weeks, the House Energy and Commerce Committee worked tirelessly
to strengthen our public health infrastructure at the national, state
and local levels to better protect our Nation and our people. This
legislation is the fruit of those efforts.
As a Member of the Homeland Security Task Force and as Vice-Chair of
the Domestic Law Enforcement Working Group, I fully appreciate and
respect the legislative effort before us. This balanced legislation,
while by no means a complete fix to our problem of bioterrorism and
homeland security, is an excellent beginning.
The Act broadly authorizes funds for planning, preparation, and
response, and places particular emphasis on the state and local level.
Importantly, the resources provided in this Act will go directly to
those in the front lines who need them the most.
Specifically, the Act authorizes more than $1 billion in grants to
states, local governments, and other public and private health care
facilities and other entities to improve planning and preparedness
activities, enhance laboratory capacity, educate and train health care
personnel, and to develop new drugs, therapies, and vaccines.
The Act authorizes $450 million for the Centers for Disease Control
and Prevention to upgrade their own capacities to deal with public
health threats, to renovate their facilities and to improve their
security. It also authorizes more than $1 billion for the Secretary of
Health and Human Services to expand our current national stockpiles of
medicines and other supplies, including the purchase of additional
smallpox vaccines.
The Act also establishes a national database of dangerous pathogens,
and imposes new registration requirements on all possessors of the 36
most deadly biological agents and toxins and mandates tough new safety
and security requirements.
Furthermore, the Act contains new protections for our Nation's food
supply by increasing by $100 million FDA resources to enable the
Secretary to hire more inspectors at our borders and develop new
methods to detect contaminated foods.
Finally, the Act provides greater protections against chemical,
biological or radiological attacks on our drinking water by authorizing
over $100 million for the development of vulnerability analyses and
emergency response plans for our drinking water systems.
This legislation is greatly needed now. As Members of Congress,
entrusted with the security of our great Nation, our greatest
responsibility is to provide the tools needed to get the job done. This
legislation does that.
I urge my colleagues to support it.
Mrs. McCARTHY of Missouri. Mr. Speaker, I rise in favor of the Public
Health Security and Bioterrorism Response Act of 2001. In the three
months since September 11, Congress has passed important legislation,
including an Emergency Supplemental Appropriations package, an airline
safety bill, and the war powers resolution to assist in the recovery,
rebuilding, and protection of our homeland. The Public Health Security
and Bioterrorism Response Act will contribute to the protection of our
country and is critical to preparing the first responders for
biological and chemical events.
This fall, I have held two conversations with the community in Kansas
City. More than 250 citizens, including police, fire, emergency
medical, public health, and government officials exchanged important
ideas on how to secure proper communication systems for emergency
response action in the event of a crisis. These first responders
expressed that the current public health resources are not sufficient
to protect the city in the face of a bioterrorist attack. The Public
Health Security and Bioterrorism Response Act of 2001 authorizes $2.69
billion for national, state, and local efforts to be prepared for
bioterrorism and other public health emergencies. This bill will
provide money to the local communities and will give them the
flexibility they desire in determining its use. Section 106, amending
Section 319H (a), page 33, states that "the Secretary may make awards
of grants and cooperative agreements to appropriate public and
nonprofit private health or education entities . . . 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."
This legislation is specifically designed for the first responders.
As it states in Section 108, this law will protect those who "Respond
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.
In a bistate community such as the metropolitan Kansas City Area a
community wide response is needed to protect our citizens. Fortunately
in my community, the Mid America Regional Council's Metropolitan
Medical Response System (MMRS) is a role model for our nation to
follow. In light of the horrific attacks on our country and the ongoing
biological and chemical threats facing our citizens this bill addresses
the needs of a metropolitan area through Sec. 108, page 40, line 6,
"(A) developing community wide plans involving the public and private
health care infrastructure to respond to bioterrorism or other public
health emergencies, which are coordinated with the capacities of
applicable national, State, and local health agencies."
These resources are essential in building our public health
infrastructure and will allow for not only the upgrading of the Centers
of Disease Control and Prevention and the purchase of the smallpox
vaccine, but also grants for local communities to develop and implement
emergency plans, the education of health care personnel, and the
continuation of state and local preparedness activities. Due to this
legislation, local governments across the country will receive
increased funds and will be better prepared to meet their communities'
public health needs.
Protection of the food supply and the security and safety of our
drinking water are national concerns that are also addressed in this
comprehensive bill. These include assessments of the threats to the
food and water supplies, increased inspection of imported food,
improved information management systems, and the development of rapid
detection inspection methods. The Public Health Security and
Bioterrorism Response Act of 2001 once implemented by our local public
health and safety authorities will help to alleviate the fears of
contamination of our food and water supplies.
Thank you Chairman Tauzin and Ranking Member, Mr. Dingell, for
constructing this bipartisan bill. I fully support the passage of this
legislation and am confident that it will contribute to the
amplification of the public health infrastructure and local
bioterrorism preparedness.
Mr. MARKEY. Mr. Speaker, I rise in support of the Public Health
Security and Bioterrorism Response Act of 2001. This strong bipartisan
effort increases funding for important public health response in the
event of a bioterrorist attacks, and ultimately will help thousands of
lives beyond those potentially threatened by bioterrorism. Today
bioterrorism calls us to arms--but let us not forget that improving the
public health system serves to protect against the more common but
equally devastating threat of infectious disease--these illnesses end
the lives of thousands of Americans daily and continue to be the third
leading cause of death in the United States. This bill is a positive
step forward in addressing this ongoing problem by improving our
currently underfunded public health system.
I am especially pleased that the bill includes provisions aimed at
increasing stockpiles of potassium iodide as a public health response
in the event of a successful terrorist attack on or accident at a
nuclear power plant as well as provisions establishing new registration
requirements and new rules limiting access to, and improving usage
procedures for "select agents."
Potassium iodide is to radiation exposure of the thyroid what Cipro
is to Anthrax. Since potassium iodide must be taken within a few hours
of exposure to radioactive iodine to be effective, it needs to be
easily obtained by the people who live close to a nuclear reactor.
While this provision doesn't go as far as I would personally prefer, it
represents a good first step towards distributing stockpiles of this
substance to local public health officials without requiring a formal
request from the States. I look forward to improving this provision as
this bill moves through the legislative process.
Under the compromise provision I worked out with the sponsors of this
bill, the Secretary of Health and Human Services would be required to
make potassium iodide available to State and local governments for
stockpiling and distribution to public facilities, such as schools and
hospitals, within 20 miles of every nuclear power plant in the United
States. Potassium iodide has been proven to protect the thyroid gland
from diseases caused by exposure to radioactive iodine released during
a nuclear catastrophe. Children are most vulnerable to radiation-
induced thyroid diseases because their thyroid glands are very active.
To receive the drug, State and local governments
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must submit a plan for distribution and utilization of the tablets in
the event of a nuclear incident. While I personally would like to see
much larger stockpiles that would cover populations even further from
the reactor, funding limitations and other factors did not make that
possible at this juncture. I remain hopeful, however, that we can build
on this first step so that we have a strong, public-health based
program in place that assures that all citizens that may need potassium
iodide in a crisis will be able to get it in a timely fashion.
I also applaud the inclusion of other provisions amending a 1996
bioterrorism law I had co-authored which required facilities that
transfer potentially lethal biologic agents to register with the
Centers for Disease Control (CDC). Today's bill expands the
requirements for registration with the CDC by requiring all facilities
that possess any one of a series of select agents to register with the
CDC and establishes new criminal offenses involving the handling of
these agents.
The Public Health Security and Bioterrorism Act of 2001 is a strong,
bipartisan step towards protecting the public from the threat of
bioterrorism or nuclear terrorism. I urge your support of this bill.
Mr. BUYER. Mr. Speaker, I rise in support of the Public Health
Security and Bioterrorism Response Act. This legislation will
strengthen our ability to conduct a war against terrorism, whether with
biological, chemical, or radiological agents.
I am particularly pleased that this legislation contains a version of
legislation I introduced to provide health professionals with access to
the very best information we have for treatment of injuries or diseases
from weapons of mass destruction or natural disasters. Our health care
professionals are not resourced or trained with the proper tools to
detect, diagnose, and treat casualties in the face of biological,
chemical and radiological weapons.
The very best information we have for medical treatment of injuries
or diseases as a result of these weapons currently resides with the
Department of Defense and the Department of Veterans Affairs. There is
no need to reinvent the wheel with regard to medical knowledge on
weapons of mass destruction. It currently resides with the federal
government. We have an obligation to get this information into the
hands of all medical professionals who need it.
Section 105 of this bill directs the Secretary of Health and Human
Services to develop and provide educational material to health
professionals for the response to weapons of mass destruction. The
Department of Defense and Department of Veterans Affairs have seats at
the table with the Secretary in this program.
It is my intent with this Section that the educational material and
curriculum that already exist within DOD and VA be adapted and provided
to health professionals in civilian settings. We cannot afford to
assume that our country will never have to experience a massive
biological, chemical, or radiological attack. The combination of DOD's
expertise in the field of treating casualties resulting from an
unconventional attack and the VA's infrastructure of 171 medical
centers, 800 clinics, satellite broadcasting capabilities and a
preexisting affiliation with 107 medical schools should enable current
and future medical professions in this entire country to become
knowledgeable and medically competent in the treatment of casualties of
weapons of mass destruction.
Health care providers all across the country are not looking for
anthrax, botulism, smallpox, and other such diseases. You do not
diagnose what you have not been training to see. Now medical
professionals will be trained to see and treat injuries or diseases
from unconventional sources.
Let me also take a moment to explain what this provision does not do.
It does not establish a federal curriculum for medical schools. It does
not mandate that medical schools teach particular educational material.
It does not set any new community standard with regard to health care
and practice.
What I am interested in doing is sharing the information that is
readily available through DOD and the VA with the civilian health care
community. Our civilian health care system must develop effective,
practical responses to these deadly weapons. It must do this through
planning, training, preparation for future terrorist attacks. Section
105 will help.
Mr. Speaker, I would also like to briefly express my view regarding
Title III of this bill, which addresses the security of our food,
especially imported food. While I am pleased that this legislation pays
special attention to the security of our food sources, let me be clear
that I will encourage the Secretary of HHS to exempt small businesses,
and farms from the registration or the recordkeeping requirements of
Title III. While I understand the bill exempts farms from
recordkeeping, I do think that it is not necessary for American farmers
to register with the Secretary of HHS as suppliers of food.
Furthermore, I do not think that small retail food establishments,
those in smaller rural communities, or those that serve a particular
niche in a larger community should be required to register. To me, this
is common sense, and I will be urging this approach to the Secretary.
This is a good measure that the Committee has worked very hard to
produce and I urge the passage of the bill.
Mr. GILLMOR. Mr. Speaker, I rise in support of this anti-terror
legislation and urge all my colleagues to vote in support of it.
Three months ago, to the date, our country was reminded that freedom
is not free. It is a painful lesson, but one from which we have learned
in the past and one we should never forget.
On one of the buildings here in Washington lies the inscription of
John Philpot Curran's famous quote: "Eternal vigilance is the price of
liberty." The legislation before us establishes the first down payment
on securing our borders. I want to congratulate Chairman Tauzin and the
distinguished Ranking Member, John Dingell, for their vision on this
project, as well as all the other subcommittee chairs, their ranking
members and the committee staff for its hard work.
As Chairman of the House Subcommittee on Environment and Hazardous
Materials, which has jurisdiction over hazardous chemicals and drinking
water, I am particularly pleased with many of the sections in this
bill. Our committee has been researching and evaluating over the last
couple of months to come up with a reasoned and responsible approach.
We have worked hard to encourage improvement in places that needed it
and avoided either slowing or punishing those who have taken pro-active
steps to secure our public's health and its environment.
For starters, Title II of this bill closes current reporting
loopholes for those people either receiving or transporting select,
dangerous toxic agents. Now, not only will there be an established
screening process to keep suspected criminals or terrorists away from
these chemicals, but all people who possess these chemicals must report
that they have them to the Federal government.
In addition, Title III of our legislation provides new procedures to
assess and detect efforts to intentionally harm our food and its
delivery system. The legislation calls for advance notice of food
coming into the country, extra maintenance of shipping records, and
grants new authorities and money to the Federal government to
commission food inspectors to handle any manpower shortages.
Finally, Title IV addresses the crucial issue of protecting our
nation's drinking water. It encourages water systems to assess their
vulnerabilities, come up with a response plan, and take any necessary
actions to secure their facilities. Next, it calls for a review of
current methods to diminish threats as well as for biomedical research
on chemical, biological, and radiological contaminants. And on the
issue of unfunded mandates, this title provides the funding to
communities to make requirements become realities.
Mr. Speaker, again, I thank you for this time to speak in favor of
this bill and I urge all my colleagues to support it. As I mentioned at
the beginning of my remarks, freedom is not free. We can take the step
of learning from September 11 and prepare for the future. Or, we can
hold our breath and "wait for the other shoe to drop." I hope we will
all decide to be vigilant.
Ms. SLAUGHTER. Mr. Speaker, I rise today in strong support of the
Public Health Security and Bioterrorism Response Act.
Three months ago, our Nation was the victim of a vicious and
unprincipled terrorist attack. Thousands of innocent Americans perished
in New York, Virginia, and Pennsylvania. We owe it to the victims,
survivors, and their families to ensure that this terrible tragedy
cannot be repeated.
The Public Health Security and Bioterrorism Response Act is an
important step toward guaranteeing the safety and security of all our
citizens. This bill will make major strides in protecting our food
supply and our water supply. It will allow the government to track the
movement of deadly biological agents and toxins, such an anthrax. And
perhaps most importantly, it will significantly upgrade our public
health infrastructure to allow for coordination, information sharing,
and dissemination of crucial data.
I would like to extend my personal gratitude to Commerce Committee
Chairman Billy Tauzin and Ranking Member John Dingell for including in
this package numerous provisions from by bill, H.R. 3106, the
Protecting America's Children Against Terrorism Act. I was proud to
sponsor this bill along with my colleague from New York, Senator
Hillary Rodham Clinton. Significant portions of this legislation were
also included in the Senate's bioterrorism package, S. 1756.
The Public Health Security and Bioterrorism Response Act includes
portions of H.R. 3106 addressing: The establishment of an advisory
committee on children and terrorism; Training for health care personnel
to meet the needs of children in the event of a public health
emergency; Increased research on issues such as
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the proper dosages of vaccines and antidotes for children; and The
inclusion of pediatric supplies and equipment in the National
Pharmaceutical Stockpile Program.
These provisions are crucial to ensure that our nation is prepared to
care for children in the event of any type of public health emergency.
The events of September 11 revealed to us the gaps in our systems for
dealing with such an emergency; it is our duty to address those needs
before we are called upon to respond again.
Mr. Speaker, I fully support the Public Health Security and
Bioterrorism Response Act and urge my colleagues to do the same.
Mr. UPTON. Mr. Speaker, I rise in strong support of the Public Health
Security and Bioterrorism Response Act. Just as the horrendous
terrorist attacks of September 11th brought home to Americans the cruel
face of hate, fanaticism, and outright evil and the need to wage war on
international terrorism, so the anthrax attacks have brought home to us
our vulnerability to bioterrorism attacks on our homefront.
What was perhaps an abstract concern has become very, very real. I
have traveled home to my district every week since September 11th, and
I have heard the real fear in mothers' and fathers' voices and in the
questions children ask me when I visit with them in their schools. Will
we be ready should our communities suffer anthrax or smallpox attacks?
Will we have the vaccines and antibiotics we need? Will emergency
response teams and emergency medical services be ready to swing quickly
into action? Will our health professionals be trained to recognize
symptoms and quickly communicate suspicious outbreaks?
While home in Michigan, I have also met with emergency response teams
at the local and state levels. While they are doing their best to
prepare coordinated responses to worst-case scenarios, they need better
tools--better weapons in their armories--to meet the threat of
bioterrorist attacks.
Enacting the comprehensive, bipartisan bill before us today will go a
long way in giving my local communities, my state, and this nation the
tools and infrastructure needed to assure individuals and families and
communities across the nation that we will have the strongest possible
defense against potential acts and the ability to respond quickly and
effectively should an attack nevertheless succeed.
Specifically, this bill will provide the funds necessary to
substantially upgrade the Centers for Disease Control and Prevention's
laboratories, facilities and communications capacities, as well as our
state and local public health department's capabilities. It will create
a national stockpile of vaccines, biologics, drugs, and medical devices
to meet the health security needs of our people. The bill recognizes
the enormous challenges that not only the CDC, but also the Food and
Drug Administration must meet if we are to be prepared with sufficient
vaccines and effective antibiotics. It provides the FDA with the
authorities needed to meet those challenges without compromising public
health. This bill will also slam shut some gaping loopholes in our
regulation of the possession of chemical and biological agents that
could be used to launch attacks. And it provides comprehensive
protection for our drinking water and food supplies.
I am proud, not only as a Member of Congress, but also as a husband
and father and community leader to be an original cosponsor of the
Public Health Security and Bioterrorism Response Act of 2001. With the
passage and enactment of this bill, we can say "YES" when a parent, a
student, or a local community leader asks us if we are prepared for
bioterrorism.
Ms. HARMAN. Mr. Speaker, I rise in strong support of the Public
Health Security and Bioterrorism Response Act of 2001, and I commend
Chairman Tauzin and Ranking Member Dingell for their leadership in
fashioning this bipartisan measure. This important piece of legislation
will take the first step toward ensuring that we will be able to
prevent--and better respond to--any future bioterrorist attack.
The National Commission on Terrorism, on which I served last year,
concluded that it is not a matter of if a bioterrorist attack will
occur, but only a question of when. We saw that expectation realized in
October and November, when anthrax-laden letters caused the death of
six Americans. And we will likely see it happen again.
Substantial evidence exists that al Qaeda and rogue states like Iraq
have attempted to acquire biological agents, and they have certainly
proven their ability to inflict mass death on the United States. the
treat of bioterrorism is real, and our nation must be prepared to
respond to any eventuality.
Our Government's response to the bioterrorist attacks of October was
deeply flawed. We have talented people and good plans, but we have been
lacking the resources and coordination to make our response effective.
We must act now to improve our terrorism response, before another
tragedy occurs.
This legislation improves the coordination and capacity of
bioterrorism response, the security of biological agents, and the
safety of our food and water supplies. It makes a substantial
investment in programs that fund communications systems, laboratory
improvements, and training programs across the nation.
Most important, the bill directs this investment to the state and
local governments that need it most. All terrorism response is local,
but in the past far too much of our counterterrorism funding has
remained at the federal level. This bill will begin to correct this
deficiency.
I am particularly glad that this bill includes funds to speed up the
renovation of CDC's buildings and facilities. I have visited to the
Centers for Disease Control and Prevention in Atlanta and seen talented
people working in shabby conditions. This legislation will invest $300
million in each of the next two years to improve the security of CDC
facilities and construct much-needed research facilities. Improving our
bioterrorism response must begin with the basics--and that means
investing in critical infrastructure and facilities.
I am proud to cosponsor this legislation, and encourage all of my
colleagues to support these needed measures.
Mr. TAUZIN. Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Terry). The question is on the motion
offered by the gentleman from Louisiana (Mr. Tauzin) that the House
suspend the rules and pass the bill, H.R. 3448.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of
those present have voted in the affirmative.
Mr. TAUZIN. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the
Chair's prior announcement, further proceedings on this motion will be
postponed.
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