Requires the maintenance of an adequate national pharmaceutical stockpile of vaccines (including a smallpox vaccine), therapies, and medical supplies for use at the Secretary's discretion in the event of a biological threat or attack or other public health emergency.
Expands the role of the Centers for Disease Control and Prevention. Directs the Secretary to provide for the establishment of a coordinated network of public health laboratories to assist with the detection of and response to a biological threat or attack.
Provides for the appointment of an Assistant Secretary for Emergency Preparedness who shall head the Office for Emergency Preparedness.
Provides for a National Disaster Medical System to provide appropriate health and social services to respond to a public health emergency, if the Secretary activates the System.
Provides for enhanced regulatory control of biological agents and toxins.
Establishes a State Bioterrorism Preparedness and Response Block Grant Program to improve State and local preparedness and response capabilities.
Amends the Clayton Act to provide for a limited antitrust exemption with respect to the development of new countermeasures against bioterrorism.
Requires, under the Public Health Service Act, the development of a crisis communications and education strategy with respect to bioterrorist threats to the food supply. Expands animal and plant health inspection service activities and authorities.
Amends the Federal Food, Drug and Cosmetic Act to expand the authority of the Food and Drug Administration with respect to food presenting a serious threat to humans or animals.
Requires the registration of food manufacturing, processing, and handling facilities.
Directs the Secretary of Agriculture to utilize existing authorities to expand Agricultural Research Service and Cooperative State Research Education and Extension Service programs to protect the food supply of the United States.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 1765 Placed on Calendar Senate (PCS)]
Calendar No. 255
107th CONGRESS
1st Session
S. 1765
To improve the ability of the United States to prepare for and respond
to a biological threat or attack.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 4, 2001
Mr. Frist (for himself, Mr. Kennedy, Mr. Allen, Mr. Daschle, Mr.
Bennett, Mr. Akaka, Mr. Bond, Mr. Baucus, Mr. Brownback, Mr. Bayh, Mr.
Burns, Mr. Biden, Mr. Campbell, Mr. Bingaman, Mr. Chafee, Mr. Breaux,
Mr. Cochran, Mrs. Carnahan, Ms. Collins, Mr. Cleland, Mr. Craig, Mrs.
Clinton, Mr. Crapo, Mr. Corzine, Mr. DeWine, Mr. Dodd, Mr. Domenici,
Mr. Dorgan, Mr. Grassley, Mr. Durbin, Mr. Hagel, Mr. Edwards, Mr.
Hutchinson, Mrs. Feinstein, Mrs. Hutchison, Mr. Harkin, Mr. Lugar, Mr.
Jeffords, Mr. McConnell, Mr. Johnson, Mr. Murkowski, Mr. Kerry, Mr.
Roberts, Ms. Landrieu, Mr. Santorum, Mr. Leahy, Ms. Snowe, Mr.
Lieberman, Mr. Specter, Mrs. Lincoln, Mr. Stevens, Ms. Mikulski, Mr.
Thomas, Mr. Miller, Mr. Thompson, Mrs. Murray, -Mr. Thurmond, Mr.
Nelson of Florida, Mr. Voinovich, Mr. Reed, Mr. Warner, Mr. Reid, Mr.
Rockefeller, Mr. Sarbanes, Mr. Torricelli, Mr. Wellstone, Mr. Schumer,
Mr. Dayton, Mr. Helms, Mr. Fitzgerald, Mr. Conrad, Mr. Hatch, Ms.
Stabenow, Mr. Inouye, Mr. Levin, and Mr. Sessions) introduced the
following bill; which was read the first time
December 5, 2001
Read the second time and placed on the calendar
December 5, 2001_______________________________________________________
A BILL
To improve the ability of the United States to prepare for and respond
to a biological threat or attack.
Be it enacted by the Senate and House of 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 ``Bioterrorism
Preparedness Act of 2001''.
(b) Table of Contents.--The table of contents of the Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--NATIONAL GOALS FOR BIOTERRORISM PREPAREDNESS
Sec. 101. Amendment to the Public Health Service Act.
TITLE II--IMPROVING THE FEDERAL RESPONSE TO BIOTERRORISM
Subtitle A--Additional Authorities
Sec. 201. Additional authorities of the Secretary; Strategic National
Pharmaceutical Stockpile.
Sec. 202. Improving the ability of the Centers for Disease Control and
Prevention to respond effectively to
bioterrorism.
Subtitle B--Coordination of Efforts and Responses
Sec. 211. Assistant Secretary of Emergency Preparedness; National
Disaster Medical System.
Sec. 212. Expanded authority of the Secretary of Health and Human
Services to respond to public health
emergencies.
Sec. 213. Public health preparedness and response to a bioterrorist
attack.
Sec. 214. The official Federal Internet site on bioterrorism.
Sec. 215. Technical amendments.
Sec. 216. Regulation of biological agents and toxins.
TITLE III--IMPROVING STATE AND LOCAL PREPAREDNESS
Subtitle A--Emergency Measures To Improve State and Local Preparedness
Sec. 301. State bioterrorism preparedness and response block grant.
Subtitle B--Improving Local Preparedness and Response Capabilities
Sec. 311. Designated bioterrorism response medical centers.
Sec. 312. Designated State public emergency announcement plan.
Sec. 313. Training for pediatric issues surrounding biological agents
used in warfare and terrorism.
Sec. 314. General Accounting Office report.
Sec. 315. Additional research.
Sec. 316. Sense of the Senate.
TITLE IV--DEVELOPING NEW COUNTERMEASURES AGAINST BIOTERRORISM
Sec. 401. Limited antitrust exemption.
Sec. 402. Developing new countermeasures against bioterrorism.
Sec. 403. Sequencing of priority pathogens.
Sec. 404. Accelerated countermeasure research and development.
Sec. 405. Accelerated approval of priority countermeasures.
Sec. 406. Use of animal trials in the approval of priority
countermeasures.
Sec. 407. Miscellaneous provisions.
TITLE V--PROTECTING THE SAFETY AND SECURITY OF THE FOOD SUPPLY
Subtitle A--General Provisions To Expand and Upgrade Security
Sec. 511. Food safety and security strategy.
Sec. 512. Expansion of Animal and Plant Health Inspection Service
activities.
Sec. 513. Expansion of Food Safety Inspection Service activities.
Sec. 514. Expansion of Food and Drug Administration activities.
Sec. 515. Biosecurity upgrades at the Department of Agriculture.
Sec. 516. Biosecurity upgrades at the Department of Health and Human
Services.
Sec. 517. Agricultural biosecurity.
Sec. 518. Biosecurity of food manufacturing, processing, and
distribution.
Subtitle B--Protection of the Food Supply
Sec. 531. Administrative detention.
Sec. 532. Debarment for repeated or serious food import violations.
Sec. 533. Maintenance and inspection of records for foods.
Sec. 534. Registration of food manufacturing, processing, and handling
facilities.
Sec. 535. Prior notice of imported food shipments.
Sec. 536. Authority to mark refused articles.
Sec. 537. Authority to commission other Federal officials to conduct
inspections.
Sec. 538. Prohibition against port shopping.
Sec. 539. Grants to States for inspections.
Sec. 540. Rule of construction.
Subtitle C--Research and Training To Enhance Food Safety and Security
Sec. 541. Surveillance and information grants and authorities.
Sec. 542. Agricultural bioterrorism research and development.
TITLE I--NATIONAL GOALS FOR BIOTERRORISM PREPAREDNESS
SEC. 101. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.
The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by
adding at the end the following:
``TITLE XXVIII--STRENGTHENING THE NATION'S PREPAREDNESS FOR
BIOTERRORISM
``SEC. 2801. CONGRESSIONAL FINDINGS ON BIOTERRORISM PREPAREDNESS.
``Congress finds that the United States should further develop and
implement a coordinated strategy to prevent, and if necessary, to
respond to biological threats or attacks upon the United States. Such
strategy should include measures for--
``(1) enabling the Federal Government to provide health
care assistance to States and localities in the event of a
biological threat or attack;
``(2) improving public health, hospital, laboratory,
communications, and emergency response personnel preparedness
and responsiveness at the State and local levels;
``(3) rapidly developing and manufacturing needed
therapies, vaccines, and medical supplies; and
``(4) enhancing the protection of the nation's food supply
and protecting agriculture against biological threats or
attacks.''.
TITLE II--IMPROVING THE FEDERAL RESPONSE TO BIOTERRORISM
Subtitle A--Additional Authorities
SEC. 201. ADDITIONAL AUTHORITIES OF THE SECRETARY; STRATEGIC NATIONAL
PHARMACEUTICAL STOCKPILE.
Title XXVIII of the Public Health Service Act, as added by section
101, is amended by adding at the end the following:
``Subtitle A--Improving the Federal Response to Bioterrorism
``SEC. 2811. AUTHORITY OF THE SECRETARY RELATED TO BIOTERRORISM
PREPAREDNESS.
``(a) Plan.--To meet the objectives of this title (and the
amendments made by the Bioterrorism Preparedness Act of 2001), and to
help the United States fully prepare for a biological threat or attack,
the Secretary, consistent with the recommendations and activities of
the working group established under section 319F(a), shall develop and
implement a coordinated plan to meet such objectives that are within
the jurisdiction of the Secretary. Such plan shall include the
development of specific criteria that will enable measurements to be
made of the progress made at the national, State, and local levels
toward achieving the national goal of bioterrorism preparedness,
including actions to strengthen the preparedness of rural communities
for a biological threat or attack.
``(b) Biennial Reports.--
``(1) In general.--Not later than 1 year after the date of
enactment of this title, and biennially thereafter, the
Secretary shall prepare and submit to Congress a report
concerning the progress made and the steps taken by the
Secretary to further the purposes of this title (and the
amendments made by the Bioterrorism Preparedness Act of 2001).
Such report shall include an assessment of the activities
conducted under section 319F(c).
``(2) Additional authority.--In the biennial report
submitted under paragraph (1), the Secretary may make
recommendations concerning--
``(A) additional legislative authority that the
Secretary determines is necessary to meet the
objectives of this title (and the amendments made by
the Bioterrorism Preparedness Act of 2001); and
``(B) additional legislative authority that the
Secretary determines is necessary under section 319 to
protect the public health in the event that a condition
described in section 319(a) occurs.
``(c) Other Reports.--Not later than 1 year after the date of
enactment of this title, the Secretary shall prepare and submit to
Congress a report concerning--
``(1) activities conducted under section 319F(b);
``(2) the characteristics that may render a rural community
uniquely vulnerable to a biological threat or attack, including
distance, lack of emergency transport, hospital or laboratory
capacity, lack of integration of Federal or State public health
networks, workforce deficits, or other relevant conditions;
``(3) in any case in which the Secretary determines that
additional legislative authority is necessary to effectively
strengthen the preparedness of rural communities for responding
to a biological threat or attack, the recommendations of the
Secretary with respect to such legislative authority; and
``(4) the need for and benefits of a National Disaster
Response Medical Volunteer Service that would be a private-
sector, community-based rapid response corps of medical
volunteers.
``SEC. 2812. STRATEGIC NATIONAL PHARMACEUTICAL STOCKPILE.
``(a) In General.--The Secretary, in coordination with the
Secretary of Veterans Affairs, shall maintain a strategic stockpile of
vaccines, therapies, and medical supplies that are adequate, as
determined by the Secretary, to meet the health needs of the United
States population, including children and other vulnerable populations,
for use at the direction of the Secretary, in the event of a biological
threat or attack or other public health emergency.
``(b) Rule of Construction.--Nothing in subsection (a) shall be
construed to prohibit the Secretary from including in the stockpile
described in such subsection such vaccines, therapies, or medical
supplies as may be necessary to meet the needs of the United States in
the event of a nuclear, radiological, or chemical attack or other
public health emergency.
``(c) Definition.--In this section, the term `stockpile' means--
``(1) a physical accumulation of the material 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 such medical supplies as shall be
described in the contract at such time as shall be specified in
the contract.
``(d) Procedures.--The Secretary, in managing the stockpile under
this section, shall--
``(1) ensure that adequate procedures are followed with
respect to the stockpile maintained under subsection (a) for
inventory management, accounting, and for the physical security
of such stockpile; and
``(2) in consultation with State and local officials, take
into consideration the timing and location of special events,
including designated national security events.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $640,000,000 for fiscal year
2002, and such sums as may be necessary for each of fiscal years 2003
through 2006.''.
SEC. 202. IMPROVING THE ABILITY OF THE CENTERS FOR DISEASE CONTROL AND
PREVENTION TO RESPOND EFFECTIVELY TO BIOTERRORISM.
(a) Revitalizing the CDC.--Section 319D of the Public Health
Service Act (42 U.S.C. 247d-4) is amended--
(1) in subsection (a), by inserting ``, and expanded,
enhanced, and improved capabilities of the Centers related to
biological threats or attacks,'' after ``modern facilities'';
(2) in subsection (b)--
(A) by inserting ``, including preparing for or
responding to biological threats or attacks,'' after
``public health activities''; and
(B) by inserting ``$60,000,000 for fiscal year
2002,''; and
(3) by adding at the end the following:
``(c) Improving Public Health Laboratory Capacity.--
``(1) In general.--The Secretary shall provide for the
establishment of a coordinated network of public health
laboratories to assist with the detection of and response to a
biological threat or attack, that may, at the discretion of the
Secretary, include laboratories that serve as regional
reference laboratories.
``(2) Authority.--The Secretary may award grants,
contracts, or cooperative agreements to carry out paragraph
(1).
``(3) Coordination.--To the maximum extent practicable, the
Secretary shall ensure that activities conducted under
paragraph (1) are coordinated with existing laboratory
preparedness activities.
``(4) Local discretion.--Use of regional laboratories, if
established under paragraph (1), shall be at the discretion of
the public health agencies of the States.
``(5) Prohibited uses.--An eligible entity may not use
amounts received under this subsection to--
``(A) purchase or improve land or purchase any
building or other facility; or
``(B) construct, repair, or alter any building or
other facility.
``(6) Supplement not supplant.--Funds appropriated under
this subsection shall be used to supplement and not supplant
other Federal, State, and local public funds provided for
activities under this subsection.
``(7) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection, $59,500,000
for fiscal year 2002, and such sums as may be necessary for
each of fiscal years 2003 through 2006.''.
(b) Education and Training.--Section 319F(e) of the Public Health
Service Act (42 U.S.C. 247d6(e)) is amended by adding at the end the
following flush sentence:
``The education and training activities described in this subsection
may be carried out through Public Health Preparedness Centers, Noble
training facilities, the Emerging Infections Program, and the Epidemic
Intelligence Service.''.
Subtitle B--Coordination of Efforts and Responses
SEC. 211. ASSISTANT SECRETARY FOR EMERGENCY PREPAREDNESS; NATIONAL
DISASTER MEDICAL SYSTEM.
Title XXVIII of the Public Health Service Act, as added by section
101, and amended by section 201, is further amended by adding at the
end the following:
``SEC. 2813. ASSISTANT SECRETARY FOR EMERGENCY PREPAREDNESS.
``(a) Appointment of Assistant Secretary for Emergency
Preparedness.--The President, with the advice and consent of the
Senate, shall appoint an individual to serve as the Assistant Secretary
for Emergency Preparedness who shall head the Office for Emergency
Preparedness. Such Assistant Secretary shall report to the Secretary.
``(b) Duties.--Subject to the authority of the Secretary, the
Assistant Secretary for Emergency Preparedness shall--
``(1) serve as the principal adviser to the Secretary on
matters relating to emergency preparedness, including preparing
for and responding to biological threats or attacks and for
developing policy; and
``(2) coordinate all functions within the Department of
Health and Human Services relating to emergency preparedness,
including preparing for and responding to biological threats or
attacks.
``SEC. 2814. NATIONAL DISASTER MEDICAL SYSTEM.
``(a) National Disaster Medical System.--
``(1) In general.--There shall be operated a system to be
known as the National Disaster Medical System (in this section
referred to as the `National System') which shall be
coordinated by the Secretary, in collaboration with the
Secretary of Defense, the Secretary of Veterans Affairs, and
the Director of the Federal Emergency Management Agency.
``(2) Functions.--The National System shall provide
appropriate health services, health-related social services
and, if necessary, auxiliary services (including mortuary and
veterinary services) to respond to the needs of victims of a
public health emergency if the Secretary activates the System
with respect to the emergency. The National System shall carry
out such ongoing activities as may be necessary to prepare for
the provision of such services.
``(b) Temporary Disaster-Response Personnel.--
``(1) In general.--For the purpose of assisting the Office
of Emergency Preparedness and the National System in carrying
out duties under this section, the Secretary may in accordance
with section 316.401 of title 5, Code of Federal Regulations
(including revisions to such section), and notwithstanding the
eligibility requirements set forth in paragraphs (1) through
(8) of section 316.402(b) of such title (including revisions),
make temporary appointments of individuals to intermittent
positions to serve as personnel of such Office or System.
``(2) Travel and subsistence.--An individual appointed
under paragraph (1) shall, in accordance with subchapter I of
chapter 57 of title 5, United States Code, be eligible for
travel, subsistence, and other necessary expenses incurred in
carrying out the duties for which the individual was appointed,
including per diem in lieu of subsistence.
``(3) Liability.--For purposes of section 224(a) and the
remedies described in such section, an individual appointed
under paragraph (1) shall, while acting within the scope of such
appointment, be considered to be an employee of the Public Health
Service performing medical, surgical, dental, or related functions.
Participation in training programs carried out by the Office of
Emergency Preparedness or Federal personnel of the National System
shall be considered within the scope of such an appointment (regardless
of whether the individual receives compensation for such
participation).
``(c) Temporary Disaster-Response Appointee.--For purposes of this
section, the term `temporary disaster-response appointee' means an
individual appointed by the Secretary under subsection (b).
``(d) Compensation for Work Injuries.--A temporary disaster-
response appointee, as designated by the Secretary, shall be deemed an
employee, and an injury sustained by such an individual while actually
serving or while participating in a uncompensated training exercise
related to such service shall be deemed `in the performance of duty',
for purposes of chapter 81 of title 5, United States Code, pertaining
to compensation for work injuries. In the event of an injury to such a
temporary disaster-response appointee, the Secretary of Labor shall be
responsible for making determinations as to whether the claimants are
entitled to compensation or other benefits in accordance with chapter
81 of title 5, United States Code.
``(e) Employment and Reemployment Rights.--
``(1) In general.--A temporary disaster-response appointee,
as designated by the Secretary, shall, when performing service
as a temporary disaster-response appointee or participating in
an uncompensated training exercise related to such service, be
deemed a person performing `service in the uniformed services'
for purposes of chapter 43 of title 38, United States Code,
pertaining to employment and reemployment rights of members in
the uniformed services. All rights and obligations of such
persons and procedures for assistance, enforcement, and
investigation shall be as provided for in chapter 43 of title
38, United States Code.
``(2) Notice of absence from position of employment.--
Preclusion of giving notice of service by disaster response
necessity 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 disaster response necessity
shall be made pursuant to regulations prescribed by the
Secretary, in consultation with the Secretary of Defense, and
shall not be subject to judicial review.
``(f) Limitation.--A temporary disaster-response appointee shall
not be deemed an employee of the Public Health Service or the Office of
Emergency Preparedness for purposes other than those specifically set
forth in this section.''.
SEC. 212. EXPANDED AUTHORITY OF THE SECRETARY OF HEALTH AND HUMAN
SERVICES TO RESPOND TO PUBLIC HEALTH EMERGENCIES.
(a) Provision of Declaration to Congress.--Section 319(a) of the
Public Health Service Act (42 U.S.C. 247d(a)) is amended by adding at
the end the following: ``Not later than 48 hours after a declaration of
a public health emergency under this section, the Secretary shall
provide a written declaration to Congress indicating that an emergency
under this section has been declared.''.
(b) Waiver of Reporting Deadlines.--Section 319 of the Public
Health Service Act (42 U.S.C. 247d) is amended by adding at the end the
following:
``(d) Waiver of 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 any sanctions otherwise applicable to such failure to
comply.''.
(c) Emergency Declaration Period.--Section 319 of the Public Health
Service Act (42 U.S.C. 247d), as amended by subsection (b), is further
amended by adding at the end the following:
``(e) Emergency Declaration Period.--A determination by the
Secretary under subsection (a) that a public health emergency exists
shall remain in effect for not longer than the 180-day period beginning
on the date of the determination. Such period may be extended by the
Secretary if--
``(1) the Secretary determines that such an extension is
appropriate; and
``(2) the Secretary provides a written notification to
Congress within 48 hours of such extension.''.
SEC. 213. PUBLIC HEALTH PREPAREDNESS AND RESPONSE TO A BIOTERRORIST
ATTACK.
Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is
amended by striking subsections (a) and (b), and inserting the
following:
``(a) Working Group on Bioterrorism.--The Secretary, in
coordination with the Secretary of Defense, the Director of the Federal
Emergency Management Agency, the Attorney General, the Secretary of
Veterans Affairs, the Secretary of Labor, and the Secretary of
Agriculture, and with other similar Federal officials as determined
appropriate, shall establish a joint interdepartmental working group on
the prevention, preparedness, and response to a biological threat or
attack on the civilian population. Such joint working group shall--
``(1) prioritize countermeasures required to treat,
prevent, or identify exposure to a biological agent or toxin
pursuant to section 351A;
``(2) coordinate and facilitate the awarding of grants,
contracts, or cooperative agreements for the development,
manufacture, distribution, and purchase of priority
countermeasures;
``(3) coordinate research on pathogens likely to be used in
a biological threat or attack on the civilian population;
``(4) develop shared standards for equipment to detect and
to protect against biological agents and toxins;
``(5) coordinate the development, maintenance, and
procedures for the release of materials from the Strategic
National Pharmaceutical Stockpile;
``(6) assess the priorities for and enhance the
preparedness of public health institutions, providers of
medical care, and other emergency service personnel (including
firefighters) to detect, diagnose, and respond (including
mental health response) to a biological threat or attack;
``(7) in the recognition that medical and public health
professionals are likely to provide much of the first response
to such an attack, develop, coordinate, enhance, and assure the
quality of joint planning and training programs that address
the public health and medical consequences of a biological
threat or attack on the civilian population between--
``(A) local firefighters, ambulance personnel,
police and public security officers, or other emergency
response personnel; and
``(B) hospitals, primary care facilities, and
public health agencies;
``(8) coordinate the development of strategies for Federal,
State, and local agencies to communicate information to the
public regarding biological threats or attacks;
``(9) develop methods to decontaminate facilities
contaminated as a result of a biological attack, including
appropriate protections for the safety of those conducting such
activities; and
``(10) ensure that the activities under this subsection
address the needs of children and other vulnerable populations.
The working group shall carry out paragraphs (1) and (2) in
consultation with the pharmaceutical, biotechnology, and medical device
industries, and other appropriate experts.
``(b) Advice to the Secretary.--The Secretary shall establish
advisory committees to provide expert recommendations to the Secretary
to assist the Secretary, including the following:
``(1) National task force on children and terrorism.--
``(A) In general.--The National Task Force on
Children and Terrorism, which shall be composed of such
Federal officials as may be appropriate to address the
special needs of children, and child health experts on
infectious disease, environmental health, toxicology,
and other relevant professional disciplines.
``(B) Duties.--The task force described in
subparagraph (A) shall provide recommendations to the
Secretary regarding--
``(i) the preparedness of the health care
system to respond to bioterrorism as it relates
to children;
``(ii) needed changes to the health care
and emergency medical service systems and
emergency medical services protocols to meet
the special needs of children with respect to a
biological threat or attack; and
``(iii) changes, if necessary, to the
Strategic National Pharmaceutical Stockpile, to
meet the special needs of children.
``(2) Emergency public information and communications task
force.--
``(A) In general.--The Emergency Public Information
and Communications (EPIC) Task Force, which shall be
composed of individuals with expertise in public
health, communications, behavioral psychology, and
other areas determined appropriate by the Secretary.
``(B) Duties.--The task force described in
subparagraph (A) shall make recommendations and report
to the Secretary on appropriate ways to communicate
information regarding biological threats or attacks to
the public, including public service announcements or
other appropriate means to communicate in a manner that
maximizes information and minimizes panic, and includes
information relevant to children and other vulnerable
populations.
``(3) Sunset.--Each Task Force established under paragraphs
(1) and (2) shall terminate on the date that is 1 year after
the date of enactment of the Bioterrorism Preparedness Act of
2001.''.
SEC. 214. THE OFFICIAL FEDERAL INTERNET SITE ON BIOTERRORISM.
It is the recommendation of Congress that there should be
established an official Federal Internet site on bioterrorism, either
directly or through provision of a grant to an entity that has
expertise in bioterrorism and the development of websites, that should
include information relevant to diverse populations (including messages
directed at the general public and such relevant groups as medical
personnel, public safety workers, and agricultural workers) and links
to appropriate State and local government sites.
SEC. 215. TECHNICAL AMENDMENTS.
Section 319C of the Public Health Service Act (42 U.S.C. 247d-3) is
amended--
(1) in subsection (a), by striking ``competitive''; and
(2) in subsection (f), by inserting ``$420,000,000 for
fiscal year 2002,'' after ``2001,''.
SEC. 216. REGULATION OF BIOLOGICAL AGENTS AND 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 BIOLOGICAL AGENTS AND TOXINS.
``(a) Regulatory Control of 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 pharmacotherapies and
immunizations to treat and prevent any
illness resulting from infection by the
agent or toxin; and
``(IV) any other criteria,
including the needs of children and
other vulnerable populations, that the
Secretary considers appropriate; and
``(ii) consult with appropriate Federal
departments and agencies, and scientific
experts representing appropriate professional
groups, including those with pediatric
expertise.
``(2) Biennial review.--The Secretary shall review and
republish the list under paragraph (1) biennially, or more
often as needed, and shall, through rulemaking, revise the list
as necessary to incorporate additions or deletions to ensure
public health, safety, and security.
``(3) Exemptions.--The Secretary may exempt from the list
under paragraph (1)--
``(A) attenuated or inactive biological agents or
toxins used in biomedical research or for legitimate
medical purposes; and
``(B) products that are cleared or approved under
the Federal Food, Drug, and Cosmetic Act or under the
Virus-Serum-Toxin Act, as amended in 1985 by the Food
Safety and Security Act.'';
``(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.--Regulations under
subsections (b) and (c) shall require registration for the possession,
use, and transfer of biological agents and toxins listed pursuant to
subsection (a)(1), and such registration shall include (if available to
the registered person) information regarding the 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 biological agents and toxins with information
regarding their characterizations.
``(e) Inspections.--The Secretary shall have the authority to
inspect persons subject to the regulations under subsections (b) and
(c) to ensure their compliance with such regulations, including
prohibitions on restricted persons under subsection (g).
``(f) Exemptions.--
``(1) In general.--The Secretary shall establish
exemptions, including exemptions from the security provisions,
from the applicability of provisions of--
``(A) the regulations issued under subsections (b)
and (c) when the Secretary determines that the
exemptions, including exemptions from the security
requirements for the use of attenuated or inactive
biological agents or toxins in biomedical research or
for legitimate medical purposes, are consistent with
protecting public health and safety; and
``(B) the regulations issued under subsection (c).
``(2) Clinical laboratories.--The Secretary shall exempt
clinical laboratories and other persons that possess, use, or
transfer biological agents and toxins listed pursuant to
subsection (a)(1) from the applicability of provisions of
regulations issued under subsections (b) and (c) only when--
``(A) such agents or toxins are presented for
diagnosis, verification, or proficiency testing;
``(B) the identification of such agents and toxins
is, when required under Federal or State law, reported
to the Secretary or other public health authorities; and
``(C) such agents or toxins are transferred or
destroyed in a manner set forth by the Secretary in
regulation.
``(g) Security Requirements for Registered Persons.--
``(1) Security.--In carrying out paragraphs (2) and (3) of
subsection (b), the Secretary shall establish appropriate
security requirements for persons possessing, using, or
transferring biological agents and toxins listed pursuant to
subsection (a)(1), considering existing standards developed by
the Attorney General for the security of government facilities,
and shall ensure compliance with such requirements as a
condition of registration under regulations issued under
subsections (b) and (c).
``(2) Limiting access to listed agents and toxins.--
Regulations issued under subsections (b) and (c) shall include
provisions--
``(A) to restrict access to biological agents and
toxins listed pursuant to subsection (a)(1) only to
those individuals who need to handle or use such agents
or toxins; and
``(B) to provide that registered persons promptly
submit the names and other identifying information for
such individuals to 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--
``(i) are restricted persons, as defined in
section 175b of title 18, United States Code;
or
``(ii) are named in a warrant issued to a
Federal or State law enforcement agency for
participation in any domestic or international
act of terrorism.
``(3) Consultation and implementation.--Regulations under
subsections (b) and (c) shall be developed in consultation with
research-performing organizations, including universities, and
implemented with timeframes that take into account the need to
continue research and education using biological agents and
toxins listed pursuant to subsection (a)(1).
``(h) Disclosure of Information.--
``(1) In general.--Any information in the 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), or any site-specific
information relating to the type, quantity, or characterization
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, including the national database
required in subsection (d), shall not be disclosed under
section 552(a) of title 5, United States Code.
``(2) Disclosures for public health and safety; congress.--
Nothing in this section may be construed as preventing the head
of any Federal agency--
``(A) from making disclosures of 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.--Any person who violates a regulation
under subsection (b) or (c) shall be subject to the United States for a
civil money penalty in an amount not exceeding $250,000 in the case of
an individual and $500,000 in the case of any other person. The
provisions of section 1128A of the Social Security Act (other than
subsections (a), (b), (h), and (i), the first sentence of subsection
(c), and paragraphs (1) and (2) of subsection (f) of such section)
shall apply to civil money penalties under this subsection in the same
manner as such provisions apply to a penalty or proceeding under
section 1128A(a) of such Act. The Secretary may delegate authority
under this section in the same manner as provided in section
1128A(j)(2) of such Act and such authority shall include all powers
described in section 6 of the Inspector General Act of 1978 (5 U.S.C.
App. 2)
``(j) Definitions.--For purposes of this section, the terms
`biological agent' and `toxin' have the same meaning as in section 178
of title 18, United States Code.''.
(2) Regulations.--
(A) Date certain for promulgation; effective date
regarding criminal and civil penalties.--Not later than
180 days after the date of the enactment of this title,
the Secretary of Health and Human Services shall
promulgate an interim final rule for carrying out
section 351A(c) of the Public Health Service Act, which
amends the Antiterrorism and Effective Death Penalty
Act of 1996. Such interim final rule will take effect
60 days after the date on which such rule is
promulgated, including for purposes of--
(i) section 175(b) of title 18, United
States Code (relating to criminal penalties),
as added by subsection (b)(1)(B) of this
section; and
(ii) section 351A(i) of the Public Health
Service Act (relating to civil penalties).
(B) Submission of registration applications.--A
person required to register for possession under the
interim final rule promulgated under subparagraph (A)
shall submit an application for such registration not
later than 60 days after the date on which such rule is
promulgated.
(3) Conforming amendment.--Subsections (d), (e), (f), and
(g) of section 511 of the Antiterrorism and Effective Death
Penalty Act of 1996 (42 U.S.C. 262 note) are repealed.
(4) Effective date.--Paragraph (1) shall take effect as if
incorporated in the Antiterrorism and Effective Death Penalty
Act of 1996, and any regulations, including the list under
subsection (d)(1) of section 511 of that Act, issued under
section 511 of that Act shall remain in effect as if issued
under section 351A of the Public Health Service Act.
(b) Select Agents.--
(1) In general.--Section 175 of title 18, United States
Code, as amended by the Uniting and Strengthening America by
Providing Appropriate Tools Required to Intercept and Obstruct
Terrorism (USA PATRIOT ACT) Act of 2001 (Public Law 107-56), is
amended--
(A) by redesignating subsections (b) and (c) as
subsections (c) and (d), respectively; and
(B) by inserting after subsection (a) the
following:
``(b) Select Agents.--
``(1) Unregistered for possession.--Whoever knowingly
possesses a biological agent or toxin where such agent or toxin
is a select agent for which such person has not obtained a
registration required by regulation issued under section
351A(c) of the Public Health Service Act shall be fined under
this title, or imprisoned for not more than 5 years, or both.
``(2) Transfer to unregistered person.--Whoever transfers a
select agent to a person who the transferor has reason to
believe has not obtained a registration required by regulations
issued under section 351A(b) or (c) of the Public Health
Service Act shall be fined under this title, or imprisoned for
not more than 5 years, or both.''.
(2) Definitions.--Section 175 of title 18, United States
Code, as amended by paragraph (1), is further amended by
striking subsection (d) and inserting the following:
``(d) Definitions.--As used in this section:
``(1) The terms `biological agent' and `toxin' have the
meanings given such terms in section 178, except that, for
purposes of subsections (b) and (c), such terms do not
encompass any biological agent or toxin that is in its
naturally occurring environment, if the biological agent or
toxin has not been cultivated, cultured, collected, or
otherwise extracted from its natural source.
``(2) The term `for use as a weapon' includes the
development, production, transfer, acquisition, retention, or
possession of any biological agent, toxin, or delivery system,
other than for prophylactic, protective, or other peaceful
purposes.
``(3) The term `select agent' means a biological agent or
toxin, as defined in paragraph (1), that is on the list that is
in effect pursuant to section 511(d)(1) of the Antiterrorism
and Effective Death Penalty Act of 1996 (Public Law 104-132),
or as subsequently revised under section 351A(a) of the Public
Health Service Act.''.
(3) Conforming amendment.--
(A) Section 175(a) of title 18, United States Code,
is amended in the second sentence by striking ``under
this section'' and inserting ``under this subsection''.
(B) Section 175(c) of title 18, United States Code,
(as redesignated by paragraph (1)), is amended by
striking the second sentence.
(c) Report to Congress.--Not later than 1 year after the date of
the enactment of this Act, the Secretary of Health and Human Services,
after consultation with other appropriate Federal agencies, shall
submit to the Congress a report that--
(1) describes the extent to which there has been compliance
by governmental and private entities with applicable
regulations under section 351A of the Public Health Service
Act, including the extent of compliance before the date of the
enactment of this Act, and including the extent of compliance
with regulations promulgated after such date of enactment;
(2) describes the actions to date and future plans of the
Secretary for updating the list of biological agents and toxins
under section 351A(a)(1) of the Public Health Service Act;
(3) describes the actions to date and future plans of the
Secretary for determining compliance with regulations under
such section 351A of the Public Health Service Act and for
taking appropriate enforcement actions; and
(4) provides any recommendations of the Secretary for
administrative or legislative initiatives regarding such
section 351A of the Public Health Service Act.
TITLE III--IMPROVING STATE AND LOCAL PREPAREDNESS
Subtitle A--Emergency Measures to Improve State and Local Preparedness
SEC. 301. STATE BIOTERRORISM PREPAREDNESS AND RESPONSE BLOCK GRANT.
(a) In General.--Section 319F of the Public Health Service Act (42
U.S.C. 247d-6) is amended by striking subsection (c) and inserting the
following:
``(c) State Bioterrorism Preparedness and Response Block Grants.--
``(1) In general.--The Secretary shall establish the State
Bioterrorism Preparedness and Response Block Grant Program
(referred to in this subsection as the `Program') under which
the Secretary shall award grants to or enter into cooperative
agreements with States, the District of Columbia, and
territories (referred to in this section as `eligible
entities') to enable such entities to prepare for and respond
to biological threats or attacks. The Secretary shall ensure
that activities conducted under this section are coordinated
with the activities conducted under this section and section
319C.
``(2) Eligibility.--To be eligible to receive amounts under
paragraph (1), a State, the District of Columbia, or a
territory shall prepare and submit to the Secretary an
application at such time, in such manner, and containing such
information as the Secretary may require, including an
assurance that the entity will--
``(A) not later than 180 days after the date on
which a grant or contract is received under this
subsection, prepare and submit to the Secretary a
Bioterrorism Preparedness and Response Plan in
accordance with subsection (c);
``(B) not later than 180 days after the date on
which a grant or contract is received under this
subsection, complete an assessment under section
319B(a), or an assessment that is substantially
equivalent as determined by the Secretary unless such
assessment has already been performed; and
``(C) establish a means by which to obtain public
comment and input on the plan and plan implementation
that shall include an advisory committee or other
similar mechanism for obtaining input from the public
at large as well as other stakeholders;
``(D) use amounts received under paragraph (1) in
accordance with the plan submitted under paragraph (3),
including making expenditures to carry out the strategy
contained in the plan;
``(E) use amounts received under paragraph (1) to
supplement and not supplant funding at levels in
existence prior to September 11, 2001 for public health
capacities or bioterrorism preparedness; and
``(F) with respect to the plan under paragraph (3),
establish reasonable criteria to evaluate the effective
performance of entities that receive funds under the
grant or agreement and shall include relevant
benchmarks in the plan.
``(3) Bioterrorism preparedness and response plan.--Not
later than 180 days after receiving amounts under this
subsection, and 1 year after such date, a State, the District
of Columbia, or a territory shall prepare and submit to the
Secretary a Bioterrorism Preparedness and Response Plan for
responding to biological threats or attacks. Recognizing the
assessment of public health capacity conducted under section
319B, such plan shall include--
``(A) a description of the program that the
eligible entity will adopt to achieve the core
capacities developed under section 319A, including
measures that meet the needs of children and other
vulnerable populations;
``(B) a description (including amounts expended by
the eligible entity for such purpose) of the programs,
projects, and activities that the eligible entity will
implement using amounts received in order to detect and
respond to biological threats or attacks, including the
manner in which the eligible entity will manage State
surveillance and response efforts and coordinate such
efforts with national efforts;
``(C) a description of the training initiatives
that the eligible entity has carried out to improve its
ability to detect and respond to a biological threat or
attack, including training and planning to protect the
health and safety of those conducting such detection
and response activities;
``(D) a description of the cleanup and
contamination prevention efforts that may be
implemented in the event of a biological threat or
attack;
``(E) a description of efforts to ensure that
hospitals and health care providers have adequate
capacity and plans in place to provide health care
items and services (including mental health services
and services to meet the needs of children and other
vulnerable populations that may include the provision
of telehealth services) in the event of a biological
threat or attack; and
``(F) other information the Secretary may by
regulation require.
``Nothing in subparagraph (E) shall be construed to require
or recommend that States establish or maintain stockpiles of
vaccines, therapies, or other medical supplies.
``(4) Use of funds.--
``(A) In general.--In coordination with the
activities conducted under this section, an eligible
entity shall use amounts received under this section
to--
``(i) conduct the assessment under section
319B to achieve the capacities described in
section 319A, if the assessment has not
previously been conducted;
``(ii) achieve the public health capacities
developed under section 319A; and
``(iii) carry out the plan under paragraph
(3).
``(B) Additional uses.--In addition to the
activities described in subparagraph (A), an eligible
entity may use amounts received under this subsection
to--
``(i) improve surveillance, detection, and
response activities to prepare for emergency
response activities including biological
threats or attacks, including training
personnel in these and other necessary
functions;
``(ii) carry out activities to improve
communications and coordination efforts within
the eligible entity and between the eligible
entity and the Federal Government, including
activities to improve information technology
and communications equipment available to
health care and public health officials for use
in responding to a biological threat or attack
or other public health emergency and including
early warning and surveillance networks that
use advanced information technology to provide early detection of
biological threats or attacks;
``(iii) plan for triage and transport
management in the event of a biological threat
or attack;
``(iv) meet the special needs of children
and other vulnerable populations during and
after a biological threat or attack, including
the expansion of 2-1-1 call centers or other
universal hotlines, or an alternative
communication plan to assist victims and their
families in receiving timely information;
``(v) improve the ability of hospitals and
other health care facilities to provide
effective health care (including mental health
care) during and after a biological threat or
attack, including the development of model
hospital preparedness plans by a hospital
accreditation organization or similar
organizations; and
``(vi) enhance the safety of workplaces in
the event of a biological threat or attack,
except that nothing in this clause shall be
construed to create a new, or deviate from an
existing, authority to regulate, modify, or
otherwise effect safety and health rules and
standards.
``(C) Prohibited uses.--An eligible entity may not
use amounts received under this subsection to--
``(i) provide inpatient services;
``(ii) make cash payments to intended
recipients of health services;
``(iii) purchase or improve land or
purchase any building or other facility;
``(iv) construct, repair, or alter any
building or other facility; or
``(v) satisfy any requirement for the
expenditure of non-Federal funds as a condition
for the receipt of Federal funds.
``(5) Amount of grant.--
``(A) In general.--Except as provided in paragraph
(2), the amount awarded to a State, the District of
Columbia, or a territory under this subsection for a
fiscal year shall be an amount that bears the same
ratio to the amount appropriated under paragraph (9)
for such fiscal year (and remaining after amounts are
made available under subparagraphs (C) and (D)) as the
total population of the State, District, or territory
bears to the total population of the United States.
``(B) Exceptions.--
``(i) Minimum amount with respect to
states.--Notwithstanding subparagraph (A) and
subject to the extent of amounts made available
under paragraph (9), a State may not receive an
award under this subsection for a fiscal year
in an amount that is less than--
``(I) $5,000,000 for any fiscal
year in which the total amount
appropriated under this subsection
equals or exceeds $667,000,000; or
``(II) 0.75 percent of the total
amount appropriated under this
subsection for any fiscal year in which
such total amount is less than
$667,000,000.
``(ii) Extraordinary needs.--
``(I) In general.--Notwithstanding
subparagraph (A) and subject to the
extent of amounts made available under
paragraph (9), the Secretary may
provide additional funds to a State,
District, or territory under this
subsection if the Secretary determines
that such State, District, or territory
has extraordinary needs with respect to
bioterrorism preparedness.
``(II) Finding with respect to the
district of columbia.--As a result of
the concentration of entities of
national significance located within
the District of Columbia, Congress
finds that the District of Columbia has
extraordinary needs with respect to
bioterrorism preparedness, and the
Secretary shall recognize such finding
for purposes of subclause (I).
``(C) Rule with respect to unexpended funds.--To
the extent that all the funds appropriated under
paragraph (9) for a fiscal year and available in such
fiscal year are not otherwise paid to eligible entities
because--
``(i) one or more eligible entities have
not submitted an application or public health
disaster plan in accordance with paragraphs (2)
and (3) for the fiscal year;
``(ii) one or more eligible entities have
notified the Secretary that they do not intend
to use the full amount awarded under this
subsection; or
``(iii) some eligible entity amounts are
offset or repaid;
such excess shall be provided to each of the remaining
eligible entities in proportion to the amount otherwise
provided to such entities under this paragraph for the
fiscal year without regard to this subparagraph.
``(D) Availability of funds.--Any amount paid to an
eligible entity for a fiscal year under this subsection
and remaining unobligated at the end of such year shall
remain available for the next fiscal year to such
entity for the purposes for which it was made.
``(6) Indian tribes.--
``(A) In general.--If the Secretary--
``(i) receives a request from the governing
body of an Indian tribe or tribal organization
within any State that funds under this
subsection be provided directly by the
Secretary to such tribe or organization; and
``(ii) determines that the members of such
tribe or tribal organization would be better
served by means of grants or agreements made
directly by the Secretary under this
subsection;
the Secretary shall reserve from amounts which would
otherwise be provided to such State under this
subsection for the fiscal year the amount determined
under subparagraph (B).
``(B) Amount.--The Secretary shall reserve for the
purpose of subparagraph (A) from amounts that would
otherwise be paid to such State under paragraph (1) an
amount equal to the amount which bears the same ratio
to the amount awarded to the State for the fiscal year
involved as the population of the Indian tribe or the
individuals represented by the tribal organization
bears to the total population of the State.
``(C) Grant.--The amount reserved by the Secretary
on the basis of a determination under this paragraph
shall be granted to the Indian tribe or tribal
organization serving the individuals for whom such a
determination has been made.
``(D) Plan.--In order for an Indian tribe or tribal
organization to be eligible for a grant for a fiscal
year under this paragraph, it shall submit to the
Secretary a plan for such fiscal year which meets such
criteria as the Secretary may prescribe.
``(E) Definitions.--In this paragraph, the terms
`Indian tribe' and `tribal organization' have the same
meaning given such terms in section 4(b) and section
4(c) of the Indian Self-Determination and Education
Assistance Act.
``(7) Withholding.--
``(A) Requirements.--
``(i) In general.--The Secretary shall,
after adequate notice and an opportunity for a
hearing conducted within the affected eligible
entity, withhold or recoup funds from any such
entity that does not use amounts received under
this subsection in accordance with the
requirements of this subsection. The Secretary
shall withhold or recoup such funds until the
Secretary finds that the reason for the
withholding or recoupment has been removed and
there is reasonable assurance that it will not
recur.
``(ii) Investigation.--The Secretary may
not institute proceedings to withhold or recoup
funds under clause (i) unless the Secretary has
conducted an investigation concerning whether
the eligible entity has used grant or agreement
amounts in accordance with the requirements of
this subsection. Investigations required by
this clause shall be conducted within the
affected entity by qualified investigators.
``(iii) Response to complaints.--The
Secretary shall respond in an expeditious
manner to complaints of a substantial or
serious nature that an eligible entity has
failed to use funds in accordance with the
requirements of this subsection.
``(iv) Minor failures.--The Secretary may
not withhold or recoup funds under clause (i)
from an eligible entity for a minor failure to
comply with the requirements of this
subsection.
``(B) Availability of information for inspection.--
Each eligible entity, and other entity which has
received funds under this section, shall make
appropriate books, documents, papers, and records
available to the Secretary or the Comptroller General
of the United States, or any of their duly authorized
representatives, for examination, copying, or
mechanical reproduction on or off the premises of the
appropriate entity upon a reasonable request therefore.
``(C) Limitation on requests for information.--
``(i) In general.--In conducting any
investigation in an eligible entity, the
Secretary or the Comptroller General of the
United States may not make a request for any
information not readily available to such
eligible entity, or an entity which has
received funds under this subsection, or make
an unreasonable request for information to be
compiled, collected, or transmitted in any form
not readily available.
``(ii) Judicial proceedings.--Clause (i)
does not apply to the collection, compilation,
or transmittal of data in the course of a
judicial proceeding.
``(8) Definition.--In this subsection, the term `State'
means any of the several States.
``(9) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection, $667,000,000
for fiscal year 2002, and such sums as may be necessary for
fiscal year 2003, and no funds are authorized to be
appropriated for subsequent fiscal years.''.
(b) Reauthorization of Other Programs.--Section 319F(i) of the
Public Health Service Act (42 U.S.C. 247d-6(i)) is amended to read as
follows:
``(i) Authorization of Appropriations.--There are authorized to be
appropriated--
``(1) to carry out subsection (d), $370,000,000 for fiscal
year 2002, and such sums as may be necessary for each
subsequent fiscal year through 2006; and
``(2) to carry out subsections (a), (b), and (e) through
(i), such sums as may be necessary for each of fiscal years
2002 through 2006.''.
Subtitle B--Improving Local Preparedness and Response Capabilities
SEC. 311. DESIGNATED BIOTERRORISM RESPONSE MEDICAL CENTERS.
Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is
amended--
(1) by redesignating subsections (d) through (h) and (i),
as subsections (e) through (i) and (l), respectively; and
(2) by inserting after subsection (c), the following:
``(d) Designated Bioterrorism Response Medical Centers.--
``(1) Grants.--The Secretary shall award project grants to
eligible entities to enable such entities, in a manner
consistent with applicable provisions of the Bioterrorism
Preparedness and Response Plan, to improve local and
bioterrorism response medical center preparedness.
``(2) Eligibility.--To be eligible for a grant under
paragraph (1), an entity shall--
``(A) be a consortium that consists of at least one
entity from each of the following categories--
``(i) a hospital including children's
hospitals, clinic, health center, or primary
care facility;
``(ii) a political subdivision of a State;
and
``(iii) a department of public health;
``(B) prepare, in consultation with the Chief
Executive Officer of the State, District, or territory
in which the hospital, clinic, health center, or
primary care facility is located, and submits to
the Secretary, an application at such time, in such manner, and
containing such information as the Secretary may require;
``(C) within a reasonable period of time after
receiving a grant under paragraph (1), meet such
technical guidelines as may be applicable under
paragraph (4); and
``(D) provide assurances satisfactory to the
Secretary that such entity shall, upon the request of
the Secretary or the Chief Executive Officer of the
State, District, or territory in which the entity is
located, during the emergency period, serve the needs
of the emergency area, including providing adequate
health care capacity, serving as a regional resource in
the diagnosis, treatment, or care for persons,
including children and other vulnerable populations,
exposed to a biological threat or attack, and accepting
the transfer of patients, where appropriate.
``(3) Use of funds.--An entity that receives a grant under
paragraph (1) shall use funds received under the grant for
activities that include--
``(A) the training of health care professionals to
enhance the ability of such personnel to recognize the
symptoms of exposure to a potential biological threat
or attack and to provide treatment to those so exposed;
``(B) the training of health care professionals to
recognize and treat the mental health consequences of a
biological threat or attack;
``(C) increasing the capacity of such entity to
provide appropriate health care for large numbers of
individuals exposed to a biological threat or attack;
``(D) the purchase of reserves of vaccines,
therapies, and other medical supplies to be used until
materials from the Strategic National Pharmaceutical
Stockpile arrive;
``(E) training and planning to protect the health
and safety of personnel involved in responding to a
biological threat or attack; or
``(F) other activities determined appropriate by
the Secretary.
``(4) Prohibited uses.--An eligible entity may not use
amounts received under this subsection to--
``(A) purchase or improve land or purchase any
building or other facility; or
``(B) construct, repair, or alter any building or
facility.
``(6) Technical assistance.--Not later than 180 days after
the date of enactment of the Bioterrorism Preparedness Act of
2001, the Secretary shall develop and publish technical
guidelines relating to equipment, training, treatment,
capacity, and personnel, relevant to the status as a
bioterrorism response medical center and the Secretary may
provide technical assistance to eligible entities, including
assistance to address the needs of children and other
vulnerable populations.''.
SEC. 312. 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. 313. TRAINING FOR PEDIATRIC ISSUES SURROUNDING BIOLOGICAL AGENTS
USED IN WARFARE AND TERRORISM.
Section 319F(f) of the Public Health Service Act (42 U.S.C. 247d-
6(e)), as so redesignated by section 311, is amended--
(1) in paragraph (1)--
(A) by inserting ``(including mental health care)''
after ``and care''; and
(B) by striking ``and'' at the end;
(2) in paragraph (2), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(3) develop educational programs for health care
professionals, recognizing the special needs of children and
other vulnerable populations.''.
SEC. 314. GENERAL ACCOUNTING OFFICE REPORT.
Section 319F(h) of the Public Health Service Act (42 U.S.C. 247d-
6(g)), as so redesignated by section 311, is amended--
(1) by striking ``Not later than 180 days after the date of
the enactment of this section, the'' and inserting ``The'';
(2) in paragraph (3), by striking ``and'' at the end;
(3) in paragraph (4), by striking the period and inserting
a semicolon; and
(4) by adding at the end the following:
``(5) the activities and cost of the Civil Support Teams of
the National Guard in responding to biological threats or
attacks against the civilian population;
``(6) the activities of the working group described in
subsection (a) and the efforts made by such group to carry out
the activities described in such subsection;
``(7) the activities and cost of the 2-1-1 call centers and
other universal hotlines; and
``(8) the activities and cost of the development and
improvement of public health laboratory capacity.''.
SEC. 315. ADDITIONAL RESEARCH.
Section 22 of the Occupational Safety and Health Act of 1970 (29
U.S.C. 671) is amended by adding at the end the following:
``(h) Research Relating to Biological Threats or Attacks in the
Workplace.--The Director shall enhance and expand research as deemed
appropriate by the Director on the health and safety of workers who are
at risk for biological threats or attacks in the workplace.''.
SEC. 316. SENSE OF THE SENATE.
It is the sense of the Senate that--
(1) many excellent university-based programs are already
functioning and developing important biodefense products and
solutions throughout the United States;
(2) accelerating the crucial work done at university
centers and laboratories will contribute significantly to the
United States capacity to defend against any biological threat
or attack;
(3) maximizing the effectiveness of, and extending the
mission of, established university programs would be one
appropriate use of the additional resources provided for in the
Bioterrorism Preparedness Act of 2001; and
(4) Congress recognizes the importance of existing public
and private university-based research, training, public
awareness, and safety related biological defense programs in
the awarding of grants and contracts made in accordance with
this Act.
TITLE IV--DEVELOPING NEW COUNTERMEASURES AGAINST BIOTERRORISM
SEC. 401. LIMITED ANTITRUST EXEMPTION.
Section 2 of the Clayton Act (15 U.S.C. 13) is amended by adding at
the end the following:
``(g) Limited Antitrust Exemption.--
``(1) Countermeasures development meetings.--
``(A) Countermeasures development meetings and
consultations.--The Secretary may conduct meetings and
consultations with parties involved in the development
of priority countermeasures for the purpose of the
development, manufacture, distribution, purchase, or
sale of priority countermeasures consistent with the
purposes of this title. The Secretary shall give notice
of such meetings and consultations to the Attorney
General and the Chairperson of the Federal Trade
Commission (referred to in this subsection as the
`Chairperson').
``(B) Meeting and consultation conditions.--A
meeting or consultation conducted under subparagraph
(A) shall--
``(i) be chaired or, in the case of a
consultation, facilitated by the Secretary;
``(ii) be open to parties involved in the
development, manufacture, distribution,
purchase, or sale of priority countermeasures,
as determined by the Secretary;
``(iii) be open to the Attorney General and
the Chairperson;
``(iv) be limited to discussions involving
the development, manufacture, distribution, or
sale of priority countermeasures, consistent
with the purposes of this title; and
``(v) be conducted in such manner as to
ensure that national security, confidential,
and proprietary information is not disclosed
outside the meeting or consultation.
``(C) Minutes.--The Secretary shall maintain
minutes of meetings and consultations under this
subsection, which shall not be disclosed under section
552 of title 5, United States Code.
``(D) Exemption.--The antitrust laws shall not
apply to meetings and consultations under this
paragraph, except that any agreement or conduct that
results from a meeting or consultation and that does
not receive an exemption pursuant to this subsection
shall be subject to the antitrust laws.
``(2) Written agreements.--The Secretary shall file a
written agreement regarding covered activities, made pursuant
to meetings or consultations conducted under paragraph (1) and
that is consistent with this paragraph, with the Attorney
General and the Chairperson for a determination of the
compliance of such agreement with antitrust laws. In addition
to the proposed agreement itself, any such filing shall
include--
``(A) an explanation of the intended purpose of the
agreement;
``(B) a specific statement of the substance of the
agreement;
``(C) a description of the methods that will be
utilized to achieve the objectives of the agreement;
``(D) an explanation of the necessity of a
cooperative effort among the particular participating
parties to achieve the objectives of the agreement; and
``(E) any other relevant information determined
necessary by the Secretary in consultation with the
Attorney General and the Chairperson.
``(3) Determination.--The Attorney General, in consultation
with the Chairperson, shall determine whether an agreement
regarding covered activities referred to in paragraph (2) would
likely--
``(A) be in compliance with the antitrust laws, and
so inform the Secretary and the participating parties;
or
``(B) violate the antitrust laws, in which case,
the filing shall be deemed to be a request for an
exemption from the antitrust laws, limited to the
performance of the agreement consistent with the
purposes of this title.
``(4) Action on request for exemption.--
``(A) In general.--The Attorney General, in
consultation with the Chairperson, shall grant, deny,
grant in part and deny in part, or propose
modifications to a request for exemption from the
antitrust laws under paragraph (3) within 15 days of
the receipt of such request.
``(B) Extension.--The Attorney General may extend
the 15-day period referred to in subparagraph (A) for
an additional period of not to exceed 10 days. Such
additional period may be further extended only by the
United States district court, upon an application by
the Attorney General after notice to the Secretary and
the parties involved.
``(C) Determination.--In granting an exemption
under this paragraph, the Attorney General, in
consultation with the Chairperson and the Secretary--
(i) must find--
``(I) that the agreement involved
is necessary to ensure the availability
of priority countermeasures;
``(II) that the exemption from the
antitrust laws would promote the public
interest; and
``(III) that there is no
substantial competitive impact to areas
not directly related to the purposes of
the agreement; and
``(ii) may consider any other factors
determined relevant by the Attorney General and
the Chairperson.
``(5) Limitation on and renewal of exemptions.--An
exemption granted under paragraph (4) shall be limited to
covered activities, and shall expire on the date that is 3
years after the date on which the exemption becomes effective
(and at 3 year intervals thereafter, if renewed) unless the
Attorney General in consultation with the Chairperson
determines that the exemption should be renewed (with
modifications, as appropriate) considering the factors
described in paragraph (4).
``(6) Limitation on parties.--The use of any information
acquired under an exempted agreement by the parties to such an
agreement for any purposes other than those specified in the
antitrust exemption granted by the Attorney General shall be
subject to the antitrust laws and any other applicable laws.
``(7) Guidelines.--The Attorney General and the Chairperson
may develop and issue guidelines to implement this subsection.
``(8) Report.--Not later than 1 year after the date of
enactment of the Bioterrorism Preparedness Act of 2001, and
annually thereafter, the Attorney General and the Chairperson
shall report to Congress on the use and continuing need for the
exemption from the antitrust laws provided by this subsection.
``(9) Sunset.--The authority of the Attorney General to
grant or renew a limited antitrust exemption under this
subsection shall expire at the end of the 6-year period that
begins on the date of enactment of the Bioterrorism
Preparedness Act of 2001.
``(h) Definitions.--In this section and title XXVIII of the Public
Health Service Act:
``(1) Antitrust laws.--The term `antitrust laws'--
``(A) has the meaning given such term in subsection
(a) of the first section of the Clayton Act (15 U.S.C.
12(a)), except that such term includes the Act of June
19, 1936 (15 U.S.C. 13 et seq.) commonly known as the
Robinson-Patman Act), and section 5 of the Federal
Trade Commission Act (15 U.S.C. 45) to the extent such
section 5 applies to unfair methods of competition; and
``(B) includes any State law similar to the laws
referred to in subparagraph (A).
``(2) Covered activities.--
``(A) In general.--Except as provided in
subparagraph (B), the term `covered activities' means
any group of activities or conduct, including
attempting to make, making, or performing a contract or
agreement or engaging in other conduct, for the purpose
of--
``(i) theoretical analysis,
experimentation, or the systematic study of
phenomena or observable facts necessary to the
development of priority countermeasures;
``(ii) the development or testing of basic
engineering techniques necessary to the
development of priority countermeasures;
``(iii) the extension of investigative
findings or theory of a scientific or technical
nature into practical application for
experimental and demonstration purposes,
including the experimental production and
testing of models, prototypes, equipment,
materials, and processes necessary to the
development of priority countermeasures;
``(iv) the production, distribution, or
marketing of a product, process, or service
that is a priority countermeasures;
``(v) the testing in connection with the
production of a product, process, or services
necessary to the development of priority
countermeasures;
``(vi) the collection, exchange, and
analysis of research or production information
necessary to the development of priority
countermeasures; or
``(vii) any combination of the purposes
described in clauses (i) through (vi);
and such term may include the establishment and
operation of facilities for the conduct of covered
activities described in clauses (i) through (vi), the
conduct of such covered activities on a protracted and
proprietary basis, and the processing of applications
for patents and the granting of licenses for the
results of such covered activities.
``(B) Exception.--The term `covered activities'
shall not include the following activities involving 2
or more persons:
``(i) Exchanging information among
competitors relating to costs, sales,
profitability, prices, marketing, or
distribution of any product, process, or
service if such information is not reasonably
necessary to carry out the purposes of covered
activities.
``(ii) Entering into any agreement or
engaging in any other conduct--
``(I) to restrict or require the
sale, licensing, or sharing of
inventions, developments, products,
processes, or services not developed
through, produced by, or distributed or
sold through such covered activities;
or
``(II) to restrict or require
participation by any person who is a
party to such covered activities in
other research and development
activities, that is not reasonably
necessary to prevent the
misappropriation of proprietary
information contributed by any person
who is a party to such covered
activities or of the results of such
covered activities.
``(iii) Entering into any agreement or
engaging in any other conduct allocating a
market with a competitor that is not expressly
exempted from the antitrust laws by a
determination under subsection (i)(4).
``(iv) Exchanging information among
competitors relating to production (other than
production by such covered activities) of a
product, process, or service if such
information is not reasonably necessary
to carry out the purpose of such covered activities.
``(v) Entering into any agreement or
engaging in any other conduct restricting,
requiring, or otherwise involving the
production of a product, process, or service
that is not so expressly exempted from the
antitrust laws by a determination under
subsection (i)(4).
``(vi) Except as otherwise provided in this
subsection, entering into any agreement or
engaging in any other conduct to restrict or
require participation by any person who is a
party to such activities, in any unilateral or
joint activity that is not reasonably necessary
to carry out the purpose of such covered
activities.
``(3) Development.--The term `development' includes the
identification of suitable compounds or biological materials,
the conduct of preclinical and clinical studies, the
preparation of an application for marketing approval, and any
other actions related to preparation of a countermeasure.
``(4) Person.--The term `person' has the meaning given such
term in subsection (a) of the first section of the Clayton Act
(15 U.S.C. 12(a)).
``(5) Priority countermeasure.--The term `priority
countermeasure' means a countermeasure, including a drug,
medical device, biological product, or diagnostic test to
treat, identify, or prevent infection by a biological agent or
toxin on the list developed under section 351A(a)(1) and
prioritized under subsection (a)(1).''.
SEC. 402. DEVELOPING NEW COUNTERMEASURES AGAINST BIOTERRORISM.
Title XXVIII of the Public Health Service Act, as added by section
101 and amended by section 201, is further amended by adding at the end
the following:
``Subtitle B--Developing New Countermeasures Against Bioterrorism
``SEC. 2841. SMALLPOX VACCINE AND OTHER VACCINE DEVELOPMENT.
``(a) In General.--The Secretary shall award contracts, enter into
cooperative agreements, or carry out such other activities as may
reasonably be required in order to ensure that the stockpile described
in section 2812 shall include the number of doses of vaccine against
smallpox and other such vaccines determined by the Secretary to be
sufficient to meet the needs of the population of the United States.
``(b) Rule of Construction.--Nothing in this section shall be
construed to limit the private distribution, purchase, or sale of
vaccines from sources other than the stockpile described in subsection
(a).
``(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $509,000,000 for fiscal year
2002, and such sums as may be necessary for each of fiscal years 2003
through 2006.
``SEC. 2842. CONTRACT AUTHORITY FOR PRIORITY COUNTERMEASURES.
``(a) In General.--The Secretary shall, to the extent the Secretary
determines necessary to achieve the purposes of this title, enter into
long-term contracts and comparable grants or cooperative agreements,
for the purpose of--
``(1) ensuring the development of priority countermeasures
that are necessary to prepare for a bioterrorist attack or
other significant disease emergency;
``(2) securing the manufacture, distribution, and adequate
supply of such countermeasures, including through the
development of novel production methods for such
countermeasures;
``(3) maintaining the Strategic National Pharmaceutical
Stockpile under section 2812; and
``(4) carrying out such other activities determined
appropriate by the Secretary to achieve the purposes of this
title.
``(b) Terms of Contracts.--Notwithstanding any other provision of
law, the Secretary may enter into a contract or cooperative agreement
under subsection (a) prior to the development, approval, or clearance
of the countermeasure that is the subject of the contract. The contract
or cooperative agreement may provide for its termination for the
convenience of the Federal Government if the contractor does not
develop the countermeasure involved. Such a contract or cooperative
agreement may--
``(1) involve one or more aspects of the development,
manufacture, purchase, or distribution of one or more uses of
one or more countermeasures; and
``(2) set forth guaranteed minimum quantities of products
and negotiated unit prices.
``SEC. 2843. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.
``(a) In General.--The Secretary, in consultation with the Attorney
General and the Secretary of Defense, may provide technical or other
assistance, to provide security to persons or facilities that conduct
development, production, distribution, or storage of priority
countermeasures.
``(b) Best Practices.--The Secretary shall develop guidelines and
best practices to enable entities eligible to receive assistance under
this section to secure their facilities against potential terrorist
attack.''.
SEC. 403. SEQUENCING OF PRIORITY PATHOGENS.
Section 319F(g) of the Public Health Service Act (42 U.S.C. 247d-
6(f)), as so redesignated by section 311, is amended--
(1) in paragraph (3), by striking ``and'' at the end;
(2) by redesignating paragraph (4) as paragraph (5); and
(3) by inserting after paragraph (3), the following:
``(4) the sequencing of the genomes of priority pathogens
as determined appropriate by the Director of the National
Institutes of Health, in consultation with the working group
established in subsection (a); and''.
SEC. 404. ACCELERATED COUNTERMEASURE RESEARCH AND DEVELOPMENT.
Section 319F(g) of the Public Health Service Act (42 U.S.C. 247d-
6(f)), as so redesignated by section 311 and amended by section 403, is
further amended--
(1) by redesignating paragraphs (1) through (5), as
subparagraphs (A) through (E), respectively and indenting
appropriately;
(2) by striking ``The Secretary'' and inserting the
following:
``(1) In general.--The Secretary''; and
(3) by adding at the end the following:
``(2) Accelerated countermeasure research and
development.--
``(A) In general.--The Secretary 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
biological agents or toxins of potential use in
a bioterrorist attack;
``(ii) the development of new vaccines and
therapeutics for use against biological agents
or toxins of potential use in a bioterrorist
attack;
``(iii) the development of diagnostic tests
to detect biological agents or toxins of
potential use in a bioterrorist attack; and
``(iv) other relevant areas of research;
with consideration given to the needs of children and
other vulnerable populations.
``(B) Priority.--The Secretary shall give priority
under this paragraph to the funding of research and
other studies related to priority countermeasures.''.
SEC. 405. ACCELERATED APPROVAL OF PRIORITY 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)
or as a device granted priority review pursuant to section 515(d)(5) of
such Act (21 U.S.C. 366e(d)(5)). Such a designation may be made prior
to the submission of--
(1) a request for designation by the sponsor or applicant;
or
(2) an application for the investigation of the drug under
section 505(i) of such Act or section 351(a)(3) of the Public
Health Service Act.
Nothing in this subsection shall be construed to prohibit a sponsor or
applicant from declining such a designation.
(b) Use of Animal Trials.--A drug for which approval is sought
under section 505(d) of the Federal Food, Drug, and Cosmetic Act or
section 351 of the Public Health Service Act on the basis of evidence
of effectiveness that is derived from animal studies under section 406
may be designated as a fast track product for purposes of this section.
(c) Priority Review.--
(1) In general.--A priority countermeasure that is a drug
or biological product shall be subject to the performance goals
established by the Commissioner of Food and Drugs for priority
drugs or biological products.
(2) Definition.--In this subsection the term ``priority
drugs or biological products'' means a drug or biological
product that is the subject of a drug application referred to
in section 101(4) of the Food and Drug Administration
Modernization Act of 1997.
SEC. 406. USE OF ANIMAL TRIALS IN THE APPROVAL OF PRIORITY
COUNTERMEASURES.
Not later than 30 days after the date of enactment of this Act, the
Secretary of Health and Human Services shall issue a final rule for the
proposal entitled ``New Drug and Biological Drug Products; Evidence
Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or
Permanently Disabling Toxic Substances When Efficacy Studies in Humans
Ethically Cannot be Conducted'' as published in the Federal Register on
October 5, 1999 (64 Fed. Reg.).
SEC. 407. MISCELLANEOUS PROVISIONS.
Title XXVIII of the Public Health Service Act, as added by section
101 and amended by section 403, is further amended by adding at the end
the following:
``Subtitle C--Miscellaneous Provisions
``SEC. 2851. SUPPLEMENT NOT SUPPLANT.
``A State or local government, or other entity to which a grant,
contract, or cooperative agreement is awarded under this title, may not
use amounts received under the grant, contract, or cooperative
agreement to supplant expenditures by the entity for activities
provided for under this title, but shall use such amounts only to
supplement such expenditures at a level at least equal to the level of
such expenditures for fiscal year 2001 (excluding those additional,
extraordinary expenditures that may have been made after September 10,
2001).''.
TITLE V--PROTECTING THE SAFETY AND SECURITY OF THE FOOD SUPPLY
Subtitle A--General Provisions to Expand and Upgrade Security
SEC. 511. FOOD SAFETY AND SECURITY STRATEGY.
(a) In General.--The President's Council on Food Safety (as
established by Executive Order 13100), the Secretary of Commerce, and
the Secretary of Transportation, shall, in consultation with the food
industry and consumer and producer groups, and the States, develop a
crisis communications and education strategy with respect to
bioterrorist threats to the food supply. Such strategy shall address
threat assessments, response and notification procedures, and risks
communications to the public.
(b) Authorization of Appropriations.--There is authorized to be
appropriated, $500,000 for fiscal year 2002, and such sums as may be
necessary in each subsequent fiscal year to implement the strategy
developed under subsection (a) in cooperation with the Secretary of
Agriculture, the Secretary of Health and Human Services, and the
Administrator of the Environmental Protection Agency.
SEC. 512. EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION SERVICE
ACTIVITIES.
(a) In General.--The Secretary of Agriculture (referred to in this
section as the ``Secretary'') shall enhance and expand the capacity of
the Animal and Plant Health Inspection Service through the conduct of
activities to--
(1) increase the inspection capacity of the Service at
international points of origin;
(2) improve surveillance at ports of entry and customs;
(3) enhance methods of protecting against the introduction
of plant and animal disease organisms by terrorists;
(4) adopt new strategies and technologies for dealing with
intentional outbreaks of plant and animal disease arising from
acts of terrorism or from unintentional introduction,
including--
(A) establishing cooperative agreements among
Veterinary Services of the Animal and Plant Health
Inspection Service, State animal health commissions and
regulatory agencies for livestock and poultry health,
and private veterinary practitioners to enhance the
preparedness and ability of Veterinary Services and the
commissions and agencies to respond to outbreaks of
such animal diseases; and
(B) strengthening planning and coordination with
State and local agencies, including--
(i) State animal health commissions and
regulatory agencies for livestock and poultry
health; and
(ii) State agriculture departments; and
(5) otherwise expand the capacity of the Service to protect
against the threat of bioterrorism.
(b) High-Tech Agriculture Early Warning and Emergency Response
System.--
(1) In general.--To provide the agricultural system of the
United States with a new, enhanced level of protection and
biosecurity that does not exist on the date of enactment of
this Act, the Secretary of Agriculture, in coordination with
the Secretary of Health and Human Services, shall implement a
fully secure surveillance and response system that utilizes, or
is capable of utilizing, field test devices capable of
detecting biological threats to animals and plants and that
electronically integrates the devices and the tests on a real-
time basis into a comprehensive surveillance, incident
management, and emergency response system.
(2) Expansion of system.--The Secretary shall expand the
system implemented under paragraph (1) as soon as practicable
to include other Federal agencies and the States where
appropriate and necessary to enhance the protection of the food
and agriculture system of the United States. To facilitate the
expansion of the system, the Secretary shall award grants to
States.
(c) Automated Recordkeeping System.--The Administrator of the
Animal and Plant Health Inspection Service shall implement a central
automated recordkeeping system to provide for the reliable tracking of
the status of animal and plant shipments, including those shipments on
hold at ports of entry and customs. The Secretary shall ensure that
such a system shall be fully accessible to or fully integrated with the
Food Safety Inspection Service.
(d) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $30,000,000 for fiscal year
2002, and such sums as may be necessary for each subsequent fiscal
year.
SEC. 513. EXPANSION OF FOOD SAFETY INSPECTION SERVICE ACTIVITIES.
(a) In General.--The Secretary of Agriculture shall enhance and
expand the capacity of the Food Safety Inspection Service through the
conduct of activities to--
(1) enhance the ability of the Service to inspect and
ensure the safety and wholesomeness of meat and poultry
products;
(2) improve the capacity of the Service to inspect
international meat and meat products, poultry and poultry
products, and egg products at points of origin and at ports of
entry;
(3) strengthen the ability of the Service to collaborate
with relevant agencies within the Department of Agriculture and
with other entities in the Federal Government, the States, and
Indian tribes through the sharing of information and
technology; and
(4) otherwise expand the capacity of the Service to protect
against the threat of bioterrorism.
(b) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $15,000,000 for fiscal year
2002, and such sums as may be necessary for each subsequent fiscal
year.
SEC. 514. EXPANSION OF FOOD AND DRUG ADMINISTRATION ACTIVITIES.
(a) In General.--The Secretary of Health and Human Services shall
expand the capacity of the Food and Drug Administration to--
(1) increase inspections to ensure the safety of the food
supply consistent with the amendments made by subtitle B; and
(2) improve linkages between the Agency and other
regulatory agencies of the Federal Government, the States, and
Indian tribes with shared responsibilities.
(b) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $59,000,000 for fiscal year
2002, and such sums as may be necessary for each subsequent fiscal
year.
SEC. 515. BIOSECURITY UPGRADES AT THE DEPARTMENT OF AGRICULTURE.
There is authorized to be appropriated for fiscal year 2002,
$180,000,000 to enable the Agricultural Research Service to conduct
building upgrades to modernize existing facilities, of which (1)
$100,000,000 is allocated for renovation, updating, and expansion of
the Biosafety Level 3 laboratory and animal research facilities at the
Plum Island Animal Disease Center (Greenport, New York), and of which
(2) $80,000,000 is allocated for the Agricultural Research Service/
Animal and Plant Health Inspection Service facility in Ames, Iowa.
There is authorized to be appropriated such sums as may be necessary in
fiscal years 2003 through 2006 for (1), (2) and the planning and design
of an Agricultural Research Service biocontainment laboratory for
poultry research in Athens, Georgia, and the planning, updating, and
renovation of the Arthropod-Borne Animal Disease Laboratory in Laramie,
Wyoming.
SEC. 516. BIOSECURITY UPGRADES AT THE DEPARTMENT OF HEALTH AND HUMAN
SERVICES.
The Secretary of Health and Human Services shall take such actions
as may be necessary to secure existing facilities of the Department of
Health and Human Services where potential animal and plant pathogens
are housed or researched.
SEC. 517. AGRICULTURAL BIOSECURITY.
(a) Land Grant Assessments.--
(1) In general.--The Secretary of Agriculture (referred to
in this section as the ``Secretary'') shall establish minimum
security standards and award grants to land grant universities
to conduct security needs assessments and to plan for
improvement of--
(A) the security of all facilities where hazardous
biological agents and toxins are stored or used for
agricultural research purposes; and
(B) communication networks that transmit
information about hazardous biological agents and
toxins.
(2) Availability of standards.--Not later than 45 days
after the establishment of security standards under paragraph
(1), the Secretary shall make such standards available to land
grant universities.
(3) Grants.--Not later than 45 days after the date of
enactment of this Act, the Secretary shall award grants, not to
exceed $50,000 each, to land grant universities to enable such
universities to conduct a security needs assessment and plan
activities to improve security. Such an assessment shall be
completed not later than 45 days after the date on which such
grant funds are received.
(b) National Hazardous Agent Inventory.--The Secretary shall carry
out activities necessary to develop a national inventory of hazardous
biological agents and toxins contained in agricultural research
facilities. Such activities shall include developing and distributing a
model inventory procedure, developing secure means of transmitting
inventory information, and conducting annual inventory activities. The
inventory shall be developed in coordination with, or as a component
of, similar systems in existence on the date of enactment of this Act.
(c) Screening Protocol.--The Secretary shall establish a national
protocol for the screening of individuals who require access to
agricultural research facilities in a manner that provides for the
protection of personal privacy.
(d) Industry-On-Farm Education.--
(1) In general.--The Secretary shall develop and implement
a program to provide education relating to farms, livestock
confinement operations, and livestock auction biosecurity to
prevent the intentional or accidental introduction of a foreign
animal disease and to attempt to discover the introduction of
such a disease before it can spread into an outbreak.
Biosecurity for livestock includes animal quarantine
procedures, blood testing of new arrivals, farm locations,
control of human movement onto farms and holding facilities,
control of vermin, and movement of vehicles onto farms.
(2) Quarantine and testing.--The Secretary shall develop
and disseminate through educational programs animal quarantine
and testing guidelines to enable farmers and producers to
better monitor new arrivals. Any educational seminars and
training carried out by the Secretary under this paragraph
shall emphasize the economic benefits of biosecurity and the
profound negative impact of an outbreak.
(3) Crop guidelines.--The Secretary may develop guidelines
and educational materials relating to biosecurity issues to be
distributed to local crop producers and facilities that handle,
process, or transport crops.
(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $20,000,000 for fiscal year
2002, and such sums as may be necessary for each subsequent fiscal
year, of which not less than $5,000,000 shall be made available in
fiscal year 2002 for activities under subsection (a).
SEC. 518. BIOSECURITY OF FOOD MANUFACTURING, PROCESSING, AND
DISTRIBUTION.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), in consultation
with the Attorney General, may award grants, contracts, or cooperative
agreements to enable food manufacturers, food processors, food
distributors, and other entities regulated by the Secretary to ensure
the safety of food through the development and implementation of
educational programs to ensure the security of their facilities and
modes of transportation against potential bioterrorist attack.
(b) Best Practices.--The Secretary may develop best practices to
enable entities eligible for funding under this section to secure their
facilities and modes of transportation against potential bioterrorist
attacks.
(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $500,000 in fiscal year 2002,
and such sums as may be necessary for each fiscal year thereafter.
Subtitle B--Protection of the Food Supply
SEC. 531. ADMINISTRATIVE DETENTION.
(a) Expanded Authority.--Section 304 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 334) is amended by adding at the end the
following:
``(h) Administrative Detention of Foods.--
``(1) Authority.--Any officer or qualified 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 the article is in violation of this
Act and presents a threat of serious adverse health
consequences or death to humans or animals.
``(2) Period of detention; approval by secretary or
secretary's designee.--
``(A) Duration.--An article of food may be detained
under this subsection for a reasonable period, not to
exceed 20 days, unless a greater period of time, not to
exceed 30 days, is necessary to enable the Secretary to
institute an action under subsection (a) or section
302.
``(B) Secretary's approval.--Before an article of
food may be ordered detained under this subsection, the
Secretary or an officer or qualified employee
designated by the Secretary must approve such order,
after determining that the article presents a threat of
serious adverse health consequences or death to humans or animals.
``(3) Security of detained article.--A detention order
under this subsection with respect to an article of food may
require that the article be labeled or marked as detained, and
may require that the article be removed to a secure facility.
An article subject to a detention order under this subsection
shall not be moved by any person from the place at which it is
ordered detained until released by the Secretary, or the
expiration of the detention period applicable to such order,
whichever occurs first.
``(4) Appeal of detention order.--Any person who would be
entitled to claim a detained article if it were seized under
subsection (a) may appeal to the Secretary the detention order
under this subsection. Within 15 days after such an appeal is
filed, the Secretary, after affording opportunity for an
informal hearing, shall by order confirm the detention order or
revoke it.
``(5) Perishable foods.--The Secretary shall provide in
regulation or in guidance for procedures for instituting and
appealing on an expedited basis administrative detention of
perishable foods.''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following new subsection:
``(bb) The movement of an article of food in violation of
an order under section 304(h), or the removal or alteration of
any mark or label required by the order in order to identify
the article as detained.''.
SEC. 532. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT VIOLATIONS.
(a) Debarment Authority.--
(1) Permissive debarment.--Section 306(b)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is
amended--
(A) by striking the period at the end of
subparagraph (B) and inserting ``; or''; and
(B) by adding at the end the following:
``(C) a person from importing a food or offering a
food for import into the United States if--
``(i) the person has been convicted of a
felony for conduct relating to the importation
into the United States of any food; or
``(ii) the person has engaged in a pattern
of importing or offering for import adulterated
food that presents a threat of serious adverse
health consequences or death to humans or
animals.''.
(2) Conforming amendment.--Section 306(b)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(2)) is
amended--
(A) in the paragraph heading, by inserting
``relating to drug applications'' after ``Debarment'';
and
(B) in the matter preceding subparagraph (A), by
striking ``paragraph (1)'' and inserting
``subparagraphs (A) and (B) of paragraph (1)''.
(3) Debarment period.--Section 306(c)(2)(A)(iii) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
335a(c)(2)(A)(iii)) is amended by striking ``subsection
(b)(2)'' and inserting ``subsection (b)(1)(C) or (b)(2)''.
(4) Termination of debarment.--Section 306(d)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(d)(3)) is
amended--
(A) in subparagraph (A)(i), by striking ``or
(b)(2)(A)'' and inserting ``, or (b)(2)(A), or
(b)(1)(C)'';
(B) in subparagraph (A)(ii)(II), by inserting ``in
applicable cases,'' before ``sufficient audits''; and
(C) in subparagraph (B), in each of clauses (i) and
(ii), by inserting ``or (b)(1)(C)'' after
``(b)(2)(B)''.
(5) Effective dates.--Section 306(l)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) is
amended--
(A) in the first sentence, by inserting ``and
subsection (b)(1)(C)'' after ``subsection (b)(2)(B)'';
and
(B) in the second sentence, by striking ``and
subsections (f) and (g) of this section'' and inserting
``subsections (f) and (g), and subsection (b)(1)(C)''.
(b) Conforming Amendment.--Section 402 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the
following:
``(h) If it is an article of food imported or offered for import
into the United States by, with the assistance of, or at the direction
of, a person debarred under section 306(b)(1)(C).''.
SEC. 533. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.
(a) In General.--Chapter IV of the Federal Food, Drug and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the
following:
``SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.
``(a) In General.--If the Secretary has reason to believe that an
article of food is adulterated or misbranded under this Act and
presents a threat of serious adverse health consequences or death to
humans or animals, each person (excluding restaurants and farms) that
manufactures, processes, packs, distributes, receives, holds, or
imports such food 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 to copy all records relating
to such food that may assist the Secretary to determine the cause and
scope of the violation. This requirement applies to all records
relating to such manufacture, processing, packing, distribution,
receipt, holding, or importation of such food 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 shall
promulgate regulations regarding the maintenance and retention of
records for inspection for not longer than 2 years by persons
(excluding restaurants and farms) that manufacture, process, pack,
transport, distribute, receive, hold, or import food, as may be needed
to allow the Secretary--
``(1) to promptly trace the source and chain of
distribution of food and its packaging to address threats of
serious adverse health consequences or death to humans or
animals; or
``(2) to determine whether food manufactured, processed,
packed, or held by the person may be adulterated or misbranded
to the extent that it presents a threat of serious adverse
health consequences or death to humans or animals under this
Act.
The Secretary may impose reduced requirements under such regulations
for small businesses with 50 or fewer employees.
``(c) Limitations.--Nothing in this section shall be construed--
``(1) to limit the authority of the Secretary to inspect
records or to require maintenance of records under any other
provision of or regulations issued under this Act;
``(2) to authorize the Secretary to impose any requirements
with respect to a food to the extent that it is within the
exclusive jurisdiction of the 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 extend to recipes for food, financial data, sales
data other than shipment data, pricing data, personnel data, or
research data; or
``(4) to alter, amend, or affect in any way the disclosure
or nondisclosure under section 552 of title 5, United States
Code, of information copied or collected under this section, or
its treatment under section 1905 of title 18, United States
Code.''.
(b) Factory Inspection.--Section 704(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374(a)) is amended--
(1) in paragraph (1), by adding after the first sentence
the following: ``In the case of any person (excluding
restaurants and farms) that manufactures, processes, packs,
transports, distributes, receives, holds, or imports foods, the
inspection shall extend to all records and other information
described in section 414(a), or required to be maintained
pursuant to section 414(b).''; and
(2) in paragraph (2), in the matter preceding subparagraph
(A), by striking ``second sentence'' and inserting ``third
sentence''.
(c) Prohibited Act.--Section 301 of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 331) is amended--
(1) in subsection (e)--
(A) by striking ``by section 412, 504, or 703'' and
inserting ``by section 412, 414, 504, 703, or 704(a)'';
and
(B) by striking ``under section 412'' and inserting
``under section 412, 414(b)''; and
(2) in section (j), by inserting ``414,'' after ``412,''.
(d) Expedited Rulemaking.--Not later than 18 months after the date
of enactment of this Act, the Secretary shall promulgate proposed and
final regulations establishing recordkeeping requirements under
subsection 414(b)(1) of the Federal Food, Drug, and Cosmetic Act.
SEC. 534. REGISTRATION OF FOOD MANUFACTURING, PROCESSING, AND HANDLING
FACILITIES.
(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.), as amended by section 533, is further
amended by adding at the end the following:
``SEC. 415. REGISTRATION OF FOOD MANUFACTURING, PROCESSING, AND
HANDLING FACILITIES.
``(a) Registration.--
``(1) In general.--Any facility engaged in manufacturing,
processing, or handling food for 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 name and address of each
facility at which, and all trade names under which, the
registrant conducts business and, when determined necessary by
the Secretary through guidance, the general food category (as
identified under section 170.3 of title 21, Code of Federal
Regulations) of any food manufactured, processed, or handled at
such facility. The registrant shall notify the Secretary in a
timely manner of changes to such information.
``(3) Procedure.--Upon receipt of a completed registration
described in paragraph (1), the Secretary shall notify the
registrant of the receipt of such 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 Authority.--The Secretary may by regulation exempt
types of retail establishments or farms from the requirements of
subsection (a) if the Secretary determines that the registration of
such facilities is not needed for effective enforcement of chapter IV
and any regulations issued under such chapter.
``(c) Facility.--In this section, the term `facility' includes any
factory, warehouse, or establishment (including a factory, warehouse,
or establishment of an importer), that manufactures, handles, or
processes food. Such term does not include restaurants.
``(d) Rule of Construction.--Nothing in this section shall be
construed to authorize the Secretary to require an application, review,
or licensing process.''.
(b) Misbranded Foods.--Section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the
following:
``(t) If it is a food from a facility for which registration has
not been submitted to the Secretary under section 415(a).''.
(c) Effective Date.--The amendment made by subsection (b) shall
take effect 180 days after the date of enactment of this Act.
SEC. 535. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.
(a) Prior Notice of Imported Food Shipments.--Section 801 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by
adding at the end the following:
``(j) Prior Notice of Imported Food Shipments.--
``(1) In general.--At least 4 hours before a food is
imported or offered for importation into the United States, the
producer, manufacturer, or shipper of the food shall provide
documentation to the Secretary of the Treasury and the
Secretary of Health and Human Services that--
``(A) identifies--
``(i) the food;
``(ii) the countries of origin of the food;
and
``(iii) the quantity to be imported; and
``(B) includes such other information as the
Secretary of Health and Human Services may require by
regulation.
``(2) Refusal of admission.--If documentation is not
provided as required by paragraph (1) at least 4 hours before
the food is imported or offered for importation, the food may
be refused admission.
``(3) Limitation.--Nothing in this subsection shall be
construed 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.).''.
(b) Prohibition of Knowingly Making False Statements.--Section 301
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended
by section 531(b), is further amended by inserting after subsection
(bb) the following:
``(cc) Knowingly making a false statement in documentation required
under section 801(j).''.
SEC. 536. AUTHORITY TO MARK REFUSED ARTICLES.
(a) Misbranded Foods.--Section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343), as amended by section 534(b), is further
amended by adding at the end the following:
``(u) If--
``(1) it has been refused admission under section 801(a);
``(2) it has not been required to be destroyed under
section 801(a);
``(3) the packaging of it does not bear a label or labeling
described in section 801(a); and
``(4) it presents a threat of serious adverse health
consequences or death to humans or animals.''.
(b) Requirement.--Section 801(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)) is amended by adding at the end the
following: ``The Secretary of Health and Human Services may require the
owner or consignee of a food that has been refused admission under this
section, and has not been required to be destroyed, to affix to the
packaging of the food a label or labeling that--
``(1) clearly and conspicuously bears the statement:
`United States: Refused Entry';
``(2) is affixed to the packaging until the food is brought
into compliance with this Act; and
``(3) has been provided at the expense of the owner or
consignee of the food.''.
(c) Rule of Construction.--Nothing in this section shall be
construed to limit the authority of the Secretary of Health and Human
Services or the Secretary of the Treasury to require the marking of
refused articles under any other provision of law.
SEC. 537. AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS TO CONDUCT
INSPECTIONS.
Section 702(a) of the Federal Food, Drug and Cosmetic Act (21
U.S.C. 372(a)) is amended in the first sentence--
(1) by inserting ``qualified'' before ``employees''; and
(2) by inserting ``or of other Federal Departments or
agencies, notwithstanding any other provision of law
restricting the use of a Department's or agency's officers,
employees, or funds,'' after ``officers and qualified employees
of the Department''.
SEC. 538. PROHIBITION AGAINST PORT SHOPPING.
Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
342), as amended by section 532(b), is further amended by adding at the
end the following:
``(i) If it is an article of food imported or offered for import
into the United States and the article of food has previously been
refused admission under section 801(a), unless the person reoffering
the article affirmatively establishes, at the expense of the owner or
consignee of the article, that the article complies with the applicable
requirements of this Act, as determined by the Secretary.''.
SEC. 539. GRANTS TO STATES FOR INSPECTIONS.
Chapter IX of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
391 et seq.) is amended by adding at the end the following:
``SEC. 910. GRANTS TO STATES FOR INSPECTIONS.
``(a) In General.--The Secretary is authorized to make grants to
States, territories, and Federally recognized Indian tribes that
undertake examinations, inspections, and investigations, and related
activities under section 702. The funds provided under such grants
shall only be available for the costs of conducting such examinations,
inspections, investigations, and related activities.
``(b) Authorization of Appropriations.--There are authorized to be
appropriated $10,000,000 for fiscal year 2002, and such sums as may be
necessary to carry out this section for each subsequent fiscal year.''.
SEC. 540. RULE OF CONSTRUCTION.
Nothing in this title, or an amendment made by this title, shall be
construed to--
(1) provide the Food and Drug Administration with
additional authority related to the regulation of meat,
poultry, and egg products; or
(2) limit the authority of the Secretary of Agriculture
with respect to such products.
Subtitle C--Research and Training to Enhance Food Safety and Security
SEC. 541. SURVEILLANCE AND INFORMATION GRANTS AND AUTHORITIES.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 317P the following:
``SEC. 317Q. FOOD SAFETY GRANTS.
``(a) In General.--The Secretary may award food safety grants to
States to expand the number of States participating in Pulsenet, the
Foodborne Diseases Active Surveillance Network, and other networks to
enhance Federal, State, and local food safety efforts.
``(b) Use of Funds.--Funds awarded under this section shall be used
by States to assist such States in meeting the costs of establishing
and maintaining the food safety surveillance, technical and laboratory
capacity needed to participate in Pulsenet, Foodborne Diseases Active
Surveillance Network, and other networks to enhance Federal, State, and
local food safety efforts.
``(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $19,500,000 for fiscal year
2002, and such sums as may be necessary for each of fiscal years 2003
through 2006.
``SEC. 317R. SURVEILLANCE OF ANIMAL AND HUMAN HEALTH.
``The Secretary, through the Commissioner of the Food and Drug
Administration and the Director of the Centers for Disease Control and
Prevention, and the Secretary of Agriculture shall develop and
implement a plan for coordinating the surveillance for zoonotic disease
and human disease.''.
SEC. 542. AGRICULTURAL BIOTERRORISM RESEARCH AND DEVELOPMENT.
(a) In General.--The Secretary of Agriculture, to the maximum
extent practicable, shall utilize existing authorities to expand
Agricultural Research Service, and Cooperative State Research Education
and Extension Service, programs to protect the food supply of the
United States by conducting activities to--
(1) enhance the capability of the Service to respond
immediately to the needs of Federal regulatory agencies
involved in protecting the food and agricultural system;
(2) continue existing partnerships with institutions of
higher education (including partnerships with 3 institutions of
higher education that are national centers for countermeasures
against agricultural bioterrorism and 7 additional institutions
with existing programs related to bioterrorism) to help form
stable, long-term programs of research, development, and
evaluation of options to enhance the biosecurity of United
States agriculture;
(3) strengthen linkages with the intelligence community to
better identify research needs and evaluate acquired materials;
(4) expand Service involvement with international
organizations dealing with plant and animal disease control;
and
(5) otherwise expand the capacity of the Service to protect
against the threat of bioterrorism.
(b) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $190,000,000 for fiscal year
2002, and such sums as may be necessary for each subsequent fiscal
year.
Calendar No. 255
107th CONGRESS
1st Session
S. 1765
_______________________________________________________________________
A BILL
To improve the ability of the United States to prepare for and respond
to a biological threat or attack.
_______________________________________________________________________
December 5, 2001
Read the second time and placed on the calendar
Introduced in Senate
Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 255.
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