[Congressional Record Volume 147, Number 171 (Tuesday, December 11, 2001)]
[House]
[Pages H9195-H9217]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




      PUBLIC HEALTH SECURITY AND BIOTERRORISM RESPONSE ACT OF 2001

  Mr. TAUZIN. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 3448) to improve the ability of the United States to 
prevent, prepare for, and respond to bioterrorism and other public 
health emergencies
  The Clerk read as follows:

                               H.R. 3448

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION. 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Public 
     Health Security and Bioterrorism Response Act of 2001''.
       (b) Table of Contents.--The table of contents of the Act is 
     as follows:

Sec. 1. Short title; table of contents.

TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH 
                              EMERGENCIES

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

Sec. 101. National preparedness and response.
Sec. 102. Assistant Secretary for Emergency Preparedness; National 
              Disaster Medical System.
Sec. 103. Improving ability of Centers for Disease Control and 
              Prevention with respect to bioterrorism and other public 
              health emergencies; facilities.
Sec. 104. Advisory committees and communications.
Sec. 105. Education of health care personnel; training regarding 
              pediatric issues.
Sec. 106. Grants regarding shortages of certain health professionals.
Sec. 107. Emergency system for verification of credentials of health 
              professions volunteers.
Sec. 108. Enhancing preparedness activities for bioterrorism and other 
              public health emergencies.
Sec. 109. Improving State and local core public health capacities.
Sec. 110. Antimicrobial resistance program.
Sec. 111. Study regarding communications abilities of public health 
              agencies.
Sec. 112. Supplies and services in lieu of award funds.
Sec. 113. Additional amendments.
Sec. 114. Study regarding local emergency response methods.

Subtitle B--National Stockpile; Development of Priority Countermeasures

Sec. 121. National stockpile.
Sec. 122. Accelerated approval of priority countermeasures.
Sec. 123. Use of animal trials in approval of certain drugs and 
              biologics; issuance of rule.
Sec. 124. Security for countermeasure development and production.
Sec. 125. Accelerated countermeasure research and development.
Sec. 126. Evaluation of new and emerging technologies regarding 
              bioterrorist attack and other public health emergencies.
Sec. 127. Potassium iodide.

        Subtitle C--Emergency Authorities; Additional Provisions

Sec. 131. Expanded authority of Secretary of Health and Human Services 
              to respond to public health emergencies.
Sec. 132. Streamlining and clarifying communicable disease quarantine 
              provisions.
Sec. 133. Emergency waiver of Medicare, Medicaid, and SCHIP 
              requirements.
Sec. 134. Provision for expiration of public health emergencies.
Sec. 135. Designated State public emergency announcement plan.
Sec. 136. Expanded research by Secretary of Energy.
Sec. 137. Agency for Toxic Substances and Disease Registry.
Sec. 138. Expanded research on worker health and safety.
Sec. 139. Technology opportunities program support.

              Subtitle D--Authorization of Appropriations

Sec. 151. Authorization of Appropriations.

 TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS

Sec. 201. Regulation of certain biological agents and toxins.

     TITLE III--AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT

                 Subtitle A--Protection of Food Supply

Sec. 301. Protection against intentional adulteration of food.
Sec. 302. Administrative detention.
Sec. 303. Permissive debarment regarding food importation.
Sec. 304. Maintenance and inspection of records for foods.
Sec. 305. Registration.
Sec. 306. Prior notice of imported food shipments.
Sec. 307. Authority to mark articles refused admission into United 
              States.
Sec. 308. Prohibition against port shopping for importation.
Sec. 309. Notices to States regarding imported food.
Sec. 310. Grants to States for inspections; response to notice 
              regarding adulterated imported food.

                 Subtitle B--Protection of Drug Supply

Sec. 311. Annual registration of foreign manufacturers; shipping 
              information; drug and device listing.
Sec. 312. Requirement of additional information regarding import 
              components intended for use in export products.

              TITLE IV--DRINKING WATER SECURITY AND SAFETY

Sec. 401. Amendment of the Safe Drinking Water Act.

TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH 
                              EMERGENCIES

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

     SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.

       The Public Health Service Act (42 U.S.C. 201 et seq.) is 
     amended by adding at the end the following title:

``TITLE XXVIII--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC 
                           HEALTH EMERGENCIES

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

     ``SEC. 2801. NATIONAL PREPAREDNESS PLAN.

       ``(a) In General.--
       ``(1) Preparedness and response regarding public health 
     emergencies.--The Secretary shall further develop and 
     implement a coordinated strategy, building upon the core 
     public health capabilities established pursuant to section 
     319A, for carrying out health-

[[Page H9196]]

     related activities to prepare for and respond effectively to 
     bioterrorism and other public health emergencies, including 
     the preparation of a plan under this section. The Secretary 
     shall periodically thereafter review and as appropriate 
     revise the plan.
       ``(2) Consultation.--The Secretary shall carry out 
     paragraph (1) in consultation with the Secretary of Defense, 
     the Director of the Federal Emergency Management Agency, the 
     Secretary of Veterans Affairs, the Attorney General, the 
     Secretary of Agriculture, the Secretary of Energy, the 
     Secretary of Labor, and the Administrator of the 
     Environmental Protection Agency, and with other appropriate 
     public and private entities.
       ``(3) National approach.--In carrying out paragraph (1), 
     the Secretary shall collaborate with the States toward the 
     goal of ensuring that the activities of the Secretary 
     regarding bioterrorism and other public health emergencies 
     are coordinated with activities of the States, including 
     through local governments, such that there is a national plan 
     for preparedness for and responding effectively to such 
     emergencies.
       ``(4) Evaluation of progress.--The plan under paragraph (1) 
     shall provide for specific benchmarks and outcome measures 
     for evaluating the progress of the Secretary and the States, 
     including local governments, with respect to the plan under 
     paragraph (1), including progress toward achieving the goals 
     specified in subsection (b).
       ``(b) Preparedness Goals.--The plan under subsection (a) 
     shall include provisions for achieving the following goals 
     with respect to preparedness for and responding effectively 
     to bioterrorism and other public health emergencies:
       ``(1) Providing effective assistance to State and local 
     governments in the event of such an emergency.
       ``(2) Ensuring that State and local governments have 
     adequate and appropriate capacity to detect and respond 
     effectively to such emergencies, including capacities for the 
     following:
       ``(A) Effective public health surveillance and reporting 
     mechanisms at the State and local levels.
       ``(B) Adequate laboratory readiness.
       ``(C) Properly trained and equipped emergency response, 
     public health, and medical personnel.
       ``(D) Health and safety protection of workers involved in 
     responding to such an emergency.
       ``(E) Public health agencies that are prepared to 
     coordinate health services (including mental health services) 
     during and after such emergencies.
       ``(F) Participation in communications networks that can 
     effectively disseminate relevant information in a timely and 
     secure manner to appropriate public and private entities and 
     to the public.
       ``(3) Developing and maintaining medical countermeasures 
     (such as drugs, vaccines and other biological products, and 
     medical devices) against biological agents that may be used 
     in such emergencies.
       ``(4) Ensuring coordination and minimizing duplication of 
     Federal, State, and local planning, preparedness, and 
     response activities, including among agencies during the 
     investigation of a suspicious disease outbreak.
       ``(5) Ensuring adequate readiness of hospitals and other 
     health care facilities to respond effectively to such 
     emergencies.
       ``(c) Evaluation of Using VA R&D Capabilities.--The 
     Secretary shall evaluate the feasibility of using the 
     biomedical research and development capabilities of the 
     Department of Veterans Affairs, in conjunction with that 
     Department's affiliations with health-professions 
     universities, as a means to assist the Secretary in achieving 
     the goals specified in subsection (b).
       ``(d) Reports to Congress.--
       ``(1) Initial report to congress.--Not later than one year 
     after the date of the enactment of the Public Health Security 
     and Bioterrorism Response Act of 2001, the Secretary shall 
     submit to the Committee on Energy and Commerce of the House 
     of Representatives, and the Committee on Health, Education, 
     Labor, and Pensions of the Senate, a report concerning 
     progress with respect to the plan under subsection (a), 
     including progress toward achieving the goals specified in 
     subsection (b).
       ``(2) Biennial reports.--Not later than 2 years after the 
     date on which the report under paragraph (1) is submitted, 
     and biennially thereafter, the Secretary shall submit to each 
     of the committees specified in such paragraph a report 
     concerning the progress made with respect to the plan under 
     subsection (a), including the goals under subsection (b).
       ``(3) Additional authority.--Reports submitted under 
     paragraph (2) by the Secretary shall make recommendations 
     concerning--
       ``(A) any additional legislative authority that the 
     Secretary determines is necessary for fully implementing the 
     plan under subsection (a), including meeting the goals under 
     subsection (b); and
       ``(B) any additional legislative authority that the 
     Secretary determines is necessary under section 319 to 
     protect the public health in the event that a condition 
     described in section 319(a) occurs.
       ``(e) Other Reports.--Not later than one year after the 
     date of the enactment of the Public Health Security and 
     Bioterrorism Response Act of 2001, the Secretary shall submit 
     to each of the committees specified in paragraph (1) a report 
     concerning--
       ``(1) the recommendations and findings of the EPIC Advisory 
     Committee under section 319F(c)(3);
       ``(2) the characteristics that may render a rural community 
     uniquely vulnerable to a biological attack, including 
     distance, lack of emergency transport, hospital or laboratory 
     capacity, lack of integration of Federal or State public 
     health networks, workforce deficits, or other relevant 
     conditions;
       ``(3) the characteristics that may render areas or 
     populations designated as medically underserved populations 
     (as defined in section 330) uniquely vulnerable to a 
     biological attack, including significant numbers of low-
     income or uninsured individuals, lack of affordable and 
     accessible health care services, insufficient public and 
     primary health care resources, lack of integration of Federal 
     or State public health networks, workforce deficits, or other 
     relevant conditions; and
       ``(4) the recommendations of the Secretary with respect to 
     additional legislative authority that the Secretary 
     determines is necessary to effectively strengthen rural 
     communities, or medically underserved populations (as defined 
     in section 330).
       ``(f) Rule of Construction.--This section may not be 
     construed as expanding or limiting any of the authorities of 
     the Secretary that, on the day before the date of the 
     enactment of the Public Health Security and Bioterrorism 
     Response Act of 2001, were in effect with respect to 
     preparing for and responding effectively to bioterrorism and 
     other public health emergencies.''.

     SEC. 102. ASSISTANT SECRETARY FOR EMERGENCY PREPAREDNESS; 
                   NATIONAL DISASTER MEDICAL SYSTEM.

       (a) In General.--Title XXVIII of the Public Health Service 
     Act, as added by section 101 of this Act, is amended by 
     adding at the end the following subtitle:

           ``Subtitle B--Emergency Preparedness and Response

     ``SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO 
                   BIOTERRORISM AND OTHER PUBLIC HEALTH 
                   EMERGENCIES.

       ``(a) Assistant Secretary for Emergency Preparedness.--
       ``(1) In general.--There is established within the 
     Department of Health and Human Services the position of 
     Assistant Secretary for Emergency Preparedness. The 
     President, by and with the advice and consent of the Senate, 
     shall appoint an individual to serve in such position. Such 
     Assistant Secretary shall report to the Secretary.
       ``(2) Duties.--Subject to the authority of the Secretary, 
     the Assistant Secretary for Emergency Preparedness shall 
     carry out the following duties:
       ``(A) Coordinate on behalf of the Secretary--
       ``(i) all interagency interfaces between the Department of 
     Health and Human Services (referred to in this paragraph as 
     the `Department') and other departments, agencies and offices 
     of the United States, including the activities of the joint 
     interdepartmental working groups under subsections (a) and 
     (b) of section 319F; and
       ``(ii) all interfaces between the Department and State and 
     local entities with responsibility for emergency 
     preparedness.
       ``(B) Coordinate the operations of the National Disaster 
     Medical System and any other emergency response activities 
     within the Department of Health and Human Services that are 
     related to bioterrorism or public health emergencies.
       ``(C) Coordinate the efforts of the Department to bolster 
     State and local emergency preparedness for a bioterrorist 
     attack or other public health emergency, and evaluate the 
     progress of such entities in meeting the benchmarks and other 
     outcome measures contained in the national plan and in 
     meeting the core public health capabilities established 
     pursuant to 319A.
       ``(D) Coordinate the activities of the Department with 
     respect to research and development of priority vaccines, 
     other biological products, drugs, and devices useful for 
     detecting or responding to a bioterrorist attack or other 
     public health emergency.
       ``(E) Coordinate the activities of the Department with 
     respect to public education, awareness, and information 
     relating to bioterrorism or other public health emergencies, 
     including the activities and recommendations of the EPIC 
     Advisory Committee under section 319F(c)(3).
       ``(F) Coordinate all other functions within the Department 
     of Health and Human Services relating to emergency 
     preparedness, including matters relating to bioterrorism and 
     other public health emergencies that are addressed in the 
     national plan under section 2801.
       ``(G) Any other duties determined appropriate by the 
     Secretary.
       ``(b) National Disaster Medical System.--
       ``(1) In general.--The Secretary shall provide for the 
     operation in accordance with this section of a system to be 
     known as the National Disaster Medical System (in this 
     section referred to as the `National System'). The Secretary 
     shall designate the Assistant Secretary for Emergency 
     Preparedness as the head of the National System, subject to 
     the authority of the Secretary.
       ``(2) Federal and state collaborative system.--
       ``(A) In general.--The National System shall be a 
     coordinated effort by the Federal agencies specified in 
     subparagraph (B), working in collaboration with the States 
     and other appropriate public or private entities,

[[Page H9197]]

     to carry out the purposes described in paragraph (3).
       ``(B) Participating federal agencies.--The Federal agencies 
     referred to in subparagraph (A) are the Department of Health 
     and Human Services, the Federal Emergency Management Agency, 
     the Department of Defense, and the Department of Veterans 
     Affairs.
       ``(3) Purpose of system.--
       ``(A) In general.--The Secretary may activate the National 
     System to--
       ``(i) provide health services, health-related social 
     services, other appropriate human services, and appropriate 
     auxiliary services to respond to the needs of victims of a 
     public health emergency (whether or not determined to be a 
     public health emergency under section 319); or
       ``(ii) be present at locations, and for periods of time, 
     specified by the Secretary on the basis that the Secretary 
     has determined that a location is at risk of a public health 
     emergency during the time specified.
       ``(B) Ongoing activities.--The National System shall carry 
     out such ongoing activities as may be necessary to prepare 
     for the provision of services described in subparagraph (A) 
     in the event that the Secretary activates the National System 
     for such purposes.
       ``(C) Test for mobilization of system.--During the one-year 
     period beginning on the date of the enactment of the Public 
     Health Security and Bioterrorism Response Act of 2001, the 
     Secretary shall conduct an exercise to test the capability 
     and timeliness of the National System to mobilize and 
     otherwise respond effectively to a bioterrorist attack or 
     other public health emergency that affects two or more 
     geographic locations concurrently. Thereafter, the Secretary 
     may periodically conduct such exercises regarding the 
     National System as the Secretary determines to be 
     appropriate.
       ``(c) Criteria.--
       ``(1) In general.--The Secretary shall establish criteria 
     for the operation of the National System.
       ``(2) Education and training of personnel.--In carrying out 
     paragraph (1), the Secretary shall establish criteria 
     regarding the education and training of individuals who 
     provide emergency services through the National System. In 
     the case of permanent, full-time positions in the Department 
     of Health and Human Services that involve significant 
     supervisory roles within the National System, the criteria 
     shall require that individuals in such positions have 
     completed appropriate education or training programs as 
     determined by the Secretary.
       ``(3) Participation agreements for non-federal entities.--
     In carrying out paragraph (1), the Secretary shall establish 
     criteria regarding the participation of States and private 
     entities in the National System, including criteria regarding 
     agreements for such participation. The criteria shall include 
     the following:
       ``(A) Provisions relating to the custody and use of Federal 
     personal property by such entities, which may in the 
     discretion of the Secretary include authorizing the custody 
     and use of such property on a reimbursable basis to respond 
     to emergency situations for which the National System has not 
     been activated by the Secretary pursuant to subsection 
     (b)(3)(A).
       ``(B) Provisions relating to circumstances in which an 
     individual or entity has agreements with both the National 
     System and another entity regarding the provision of 
     emergency services by the individual. Such provisions shall 
     address the issue of priorities among the agreements 
     involved.
       ``(d) Intermittent Disaster-Response Personnel.--
       ``(1) In general.--For the purpose of assisting the 
     National System in carrying out duties under this section, 
     the Secretary may appoint individuals to serve as 
     intermittent personnel of such System in accordance with 
     applicable civil service laws and regulations.
       ``(2) Liability.--For purposes of section 224(a) and the 
     remedies described in such section, an individual appointed 
     under paragraph (1) shall, while acting within the scope of 
     such appointment, be considered to be an employee of the 
     Public Health Service performing medical, surgical, dental, 
     or related functions. With respect to the participation of 
     individuals appointed under paragraph (1) in training 
     programs authorized by the Assistant Secretary for Emergency 
     Preparedness or a comparable official of any Federal agency 
     specified in subsection (b)(2)(B), acts of individuals so 
     appointed that are within the scope of such participation 
     shall be considered within the scope of the appointment under 
     paragraph (1) (regardless of whether the individuals receive 
     compensation for such participation).
       ``(e) Certain Employment Issues Regarding Intermittent 
     Appointments.--
       ``(1) Intermittent disaster-response appointee.--For 
     purposes of this subsection, the term `intermittent disaster-
     response appointee' means an individual appointed by the 
     Secretary under subsection (d).
       ``(2) Compensation for work injuries.--An intermittent 
     disaster-response appointee shall, while acting in the scope 
     of such appointment, be considered to be an employee of the 
     Public Health Service performing medical, surgical, dental, 
     or related functions, and an injury sustained by such an 
     individual shall be deemed `in the performance of duty', for 
     purposes of chapter 81 of title 5, United States Code, 
     pertaining to compensation for work injuries. With respect to 
     the participation of individuals appointed under subsection 
     (d) in training programs authorized by the Assistant 
     Secretary for Emergency Preparedness or a comparable official 
     of any Federal agency specified in subsection (b)(2)(B), 
     injuries sustained by such an individual, while acting within 
     the scope of such participation, also shall be deemed `in the 
     performance of duty' for purposes of chapter 81 of title 5, 
     United States Code (regardless of whether the individuals 
     receive compensation for such participation). In the event of 
     an injury to such an intermittent disaster-response 
     appointee, the Secretary of Labor shall be responsible for 
     making determinations as to whether the claimant is entitled 
     to compensation or other benefits in accordance with chapter 
     81 of title 5, United States Code.
       ``(3) Employment and reemployment rights.--
       ``(A) In general.--Service as an intermittent disaster-
     response appointee when the Secretary activates the National 
     System or when the individual participates in a training 
     program authorized by the Assistant Secretary for Emergency 
     Preparedness or a comparable official of any Federal agency 
     specified in subsection (b)(2)(B) shall be deemed `service in 
     the uniformed services' for purposes of chapter 43 of title 
     38, United States Code, pertaining to employment and 
     reemployment rights of individuals who have performed service 
     in the uniformed services (regardless of whether the 
     individual receives compensation for such participation). All 
     rights and obligations of such persons and procedures for 
     assistance, enforcement, and investigation shall be as 
     provided for in chapter 43 of title 38, United States Code.
       ``(B) Notice of absence from position of employment.--
     Preclusion of giving notice of service by necessity of 
     Service as an intermittent disaster-response appointee when 
     the Secretary activates the National System shall be deemed 
     preclusion by `military necessity' for purposes of section 
     4312(b) of title 38, United States Code, pertaining to giving 
     notice of absence from a position of employment. A 
     determination of such necessity shall be made by the 
     Secretary, in consultation with the Secretary of Defense, and 
     shall not be subject to judicial review.
       ``(4) Limitation.--An intermittent disaster-response 
     appointee shall not be deemed an employee of the Department 
     of Health and Human Services for purposes other than those 
     specifically set forth in this section.
       ``(f) Definition.--For purposes of this section, the term 
     `auxiliary services' includes mortuary services, veterinary 
     services, and other services that are determined by the 
     Secretary to be appropriate with respect to the needs 
     referred to in subsection (b)(3)(A).
       ``(g) Authorization of Appropriations.--For the purpose of 
     providing for the Assistant Secretary for Emergency 
     Preparedness and the operations of the National System, other 
     than purposes for which amounts in the Public Health 
     Emergency Fund under section 319 are available, there are 
     authorized to be appropriated such sums as may be necessary 
     for each of the fiscal years 2002 through 2006.''.
       (b) Sense of Congress Regarding Resources of National 
     System.--It is the sense of the Congress that the Secretary 
     of Health and Human Services should provide sufficient 
     resources to individuals and entities tasked to carry out the 
     duties of the National Disaster Medical System for 
     reimbursement of expenses, operations, purchase and 
     maintenance of equipment, training, and other funds expended 
     in furtherance of such National System.

     SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL 
                   AND PREVENTION WITH RESPECT TO BIOTERRORISM AND 
                   OTHER PUBLIC HEALTH EMERGENCIES; FACILITIES.

       Section 319D of the Public Health Service Act (42 U.S.C. 
     247d-4) is amended to read as follows:

     ``SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND 
                   PREVENTION.

       ``(a) Findings.--Congress finds that the Centers for 
     Disease Control and Prevention have an essential role in 
     defending against and combatting public health threats of the 
     21st century and requires secure and modern facilities, and 
     expanded and improved capabilities related to biological 
     threats or attacks or other public health emergencies, 
     sufficient to enable such Centers to conduct this important 
     mission.
       ``(b) Improving the Capacities of the Centers for Disease 
     Control and Prevention.--
       ``(1) In general.--The Secretary shall expand, enhance, and 
     improve the capabilities of the Centers for Disease Control 
     and Prevention relating to preparedness for and responding 
     effectively to bioterrorism and other public health 
     emergencies. Activities that may be carried out under the 
     preceding sentence include--
       ``(A) expanding or enhancing the training of personnel;
       ``(B) improving communications facilities and networks;
       ``(C) improving capabilities for public health surveillance 
     and reporting activities;
       ``(D) improving laboratory facilities related to 
     bioterrorism, including increasing the security of such 
     facilities; and
       ``(E) such other activities as the Secretary determines 
     appropriate.
       ``(2) Improving public health laboratory capacity.--
       ``(A) In general.--The Secretary, directly or through 
     awards of grants, contracts, or cooperative agreements, shall 
     provide for the

[[Page H9198]]

     establishment of a coordinated network of public health 
     laboratories, that may, at the discretion of the Secretary, 
     include laboratories that serve as regional reference 
     laboratories.
       ``(B) Priority.--In carrying out subparagraph (A), the 
     Secretary shall give priority to projects that include State 
     or local government financial commitments, that seek to 
     incorporate multiple public health and safety services or 
     diagnostic databases into an integrated public health or 
     regional reference laboratory, and that cover geographic 
     areas lacking advanced diagnostic and safety-level laboratory 
     capabilities.
       ``(3) National public health communications and 
     surveillance network.--
       ``(A) In general.--The Secretary, directly or through 
     awards of grants, contracts, or cooperative agreements, shall 
     provide for the establishment of integrated public health 
     communications and surveillance networks between and among--
       ``(i) Federal, State, and local public health officials;
       ``(ii) public and private health-related laboratories, 
     hospitals, and other health care facilities; and
       ``(iii) any other entities determined appropriate by the 
     Secretary.
       ``(B) Requirements.--The Secretary shall ensure that 
     networks under subparagraph (A) allow for the timely sharing 
     and discussion, in a secure manner, of essential information 
     concerning a bioterrorist attack or other public health 
     emergency, or recommended methods for responding to such an 
     attack or emergency.
       ``(4) Continuity of effort.--To the maximum extent 
     practicable, the Secretary, in conducting activities under 
     paragraphs (1) through (3), shall administer such activities 
     in a manner that intensifies, expands, or enhances activities 
     being carried out on the date of enactment of this 
     subsection.
       ``(c) Facilities.--
       ``(1) In general.--The Director of the Centers for Disease 
     Control and Prevention may design, construct, and equip new 
     facilities, renovate existing facilities (including 
     laboratories, laboratory support buildings, scientific 
     communication facilities, transshipment complexes, secured 
     and isolated parking structures, office buildings, and other 
     facilities and infrastructure), and upgrade security of such 
     facilities, in order to better conduct the capacities 
     described in section 319A, and for supporting related public 
     health activities.
       ``(2) Multiyear contracting authority.--For any project of 
     designing, constructing, equipping, or renovating any 
     facility under paragraph (1), the Director of the Centers for 
     Disease Control and Prevention may enter into a single 
     contract or related contracts that collectively include the 
     full scope of the project, and the solicitation and contract 
     shall contain the clause `availability of funds' found at 
     section 52.232-18 of title 48, Code of Federal Regulations.
       ``(d) Authorization of Appropriations.--
       ``(1) In general.--For the purposes of achieving the 
     mission of the Centers for Disease Control and Prevention 
     described in subsection (a), for carrying out subsection (b), 
     for better conducting the capacities described in section 
     319A, and for supporting related public health activities, 
     there are authorized to be appropriated such sums as may be 
     necessary for each of the fiscal years 2002 through 2006.
       ``(2) Facilities.--For the purpose of carrying out 
     subsection (c), there are authorized to be appropriated 
     $300,000,000 for each of the fiscal years 2002 and 2003, and 
     such sums as may be necessary for each of the fiscal years 
     2004 through 2006.''.

     SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS.

       Section 319F of the Public Health Service Act (42 U.S.C. 
     247d-6) is amended--
       (1) by redesignating subsections (c) through (i) as 
     subsections (e) through (k), respectively; and
       (2) by inserting after subsection (b) the following 
     subsections:
       ``(c) Advice to the Federal Government.--
       ``(1) Required advisory committees.--In coordination with 
     the working groups under subsections (a) and (b), the 
     Secretary shall establish advisory committees in accordance 
     with paragraphs (2) and (3) to provide expert recommendations 
     to assist such working groups in carrying out their 
     respective responsibilities under subsections (a) and (b).
       ``(2) National advisory committee on children and 
     terrorism.--
       ``(A) In general.--For purposes of paragraph (1), the 
     Secretary shall establish an advisory committee to be known 
     as the National Advisory Committee on Children and Terrorism 
     (referred to in this paragraph as the `Advisory Committee').
       ``(B) Duties.--The Advisory Committee shall provide 
     recommendations regarding--
       ``(i) the preparedness of the health care (including mental 
     health care) system to respond to bioterrorism as it relates 
     to children;
       ``(ii) needed changes to the health care and emergency 
     medical service systems and emergency medical services 
     protocols to meet the special needs of children; and
       ``(iii) changes, if necessary, to the national stockpile 
     under section 121 of the Public Health Security and 
     Bioterrorism Response Act of 2001 to meet the special needs 
     of children.
       ``(C) Composition.--The Advisory Committee shall be 
     composed of such Federal officials as may be appropriate to 
     address the special needs of the diverse population groups of 
     children, and child health experts on infectious disease, 
     environmental health, toxicology, and other relevant 
     professional disciplines.
       ``(D) Termination.--The Advisory Committee terminates one 
     year after the date of the enactment of the Public Health 
     Security and Bioterrorism Response Act of 2001.
       ``(3) Emergency public information and communications 
     advisory committee.--
       ``(A) In general.--For purposes of paragraph (1), the 
     Secretary shall establish an advisory committee to be known 
     as the Emergency Public Information and Communications 
     Advisory Committee (referred to in this paragraph as the 
     `EPIC Advisory Committee').
       ``(B) Duties.--The EPIC Advisory Committee shall make 
     recommendations and report on appropriate ways to communicate 
     public-health information regarding biological attacks to the 
     public.
       ``(C) Composition.--The EPIC Advisory Committee shall be 
     composed of individuals representing a diverse group of 
     experts in public health, communications, behavioral 
     psychology, and other areas determined appropriate by the 
     Secretary.
       ``(D) Dissemination.--The Secretary shall ensure that the 
     recommendations of the EPIC Advisory Committee are widely 
     disseminated to the media, State and local governments, 
     poison control centers, and others as the Secretary 
     determines appropriate.
       ``(E) Termination.--The EPIC Advisory Committee terminates 
     one year after the date of the enactment of the Public Health 
     Security and Bioterrorism Response Act of 2001.
       ``(d) Strategy for Communication of Information Regarding 
     Biological Attack.--In coordination with the joint 
     interdepartmental working group under subsection (b), the 
     Secretary, acting through the Assistant Secretary for 
     Emergency Preparedness, shall develop a strategy for 
     effectively communicating information regarding a biological 
     attack, and shall develop means by which to communicate such 
     information. The Secretary may carry out the preceding 
     sentence directly or through grants, contracts, or 
     cooperative agreements.''.

     SEC. 105. EDUCATION OF HEALTH CARE PERSONNEL; TRAINING 
                   REGARDING PEDIATRIC ISSUES.

       Section 319F(g) of the Public Health Service Act, as 
     redesignated by section 104(1) of this Act, is amended to 
     read as follows:
       ``(g) Education; Training Regarding Pediatric Issues.--
       ``(1) Materials; core curriculum.--The Secretary, in 
     collaboration with members of the working group described in 
     subsection (b), and professional organizations and societies, 
     shall--
       ``(A) develop materials for teaching the elements of a core 
     curriculum for the recognition and identification (including 
     proficiency testing) of potential bioweapons and other agents 
     that may create a public health emergency, and for the care 
     of victims of such emergencies, recognizing the special needs 
     of children and other vulnerable populations, to public 
     health officials, medical professionals, emergency physicians 
     and other emergency department staff, laboratory personnel, 
     and other personnel working in health care facilities 
     (including poison control centers);
       ``(B) develop a core curriculum and materials for 
     community-wide planning by State and local governments, 
     hospitals and other health care facilities, emergency 
     response units, and appropriate public and private sector 
     entities to respond to a bioterrorist attack or other public 
     health emergency;
       ``(C) provide for dissemination and teaching of the 
     materials described in subparagraphs (A) and (B) by all 
     appropriate means, including telemedicine, long-distance 
     learning, or other such means; and
       ``(D) to the extent practicable, establish and maintain an 
     electronic database of individuals participating in training 
     or education programs carried out under this section, for the 
     purpose of providing continuing education materials and 
     information to such participants.
       ``(2) Grants.--In carrying out paragraph (1), the Secretary 
     may award grants to, or enter into cooperative agreements 
     with, professional organizations and societies, private 
     accrediting organizations, or other nonprofit institutions or 
     entities meeting criteria established by the Secretary, and 
     may enter into interagency cooperative agreements with other 
     Federal agencies.
       ``(3) Health-Related Assistance for Emergency Response 
     Personnel Training.--The Secretary, in consultation with the 
     Attorney General and the Director of the Federal Emergency 
     Management Agency, may provide assistance with respect to 
     health-related aspects of emergency response personnel 
     training carried out by the Department of Justice and the 
     Federal Emergency Management Agency.''.

     SEC. 106. GRANTS REGARDING SHORTAGES OF CERTAIN HEALTH 
                   PROFESSIONALS.

       Part B of title III of the Public Health Service Act (42 
     U.S.C. 243 et seq.) is amended by inserting after section 
     319G the following section:

     ``SEC. 319H. GRANTS REGARDING TRAINING AND EDUCATION OF 
                   CERTAIN HEALTH PROFESSIONALS.

       ``(a) In General.--The Secretary may make awards of grants 
     and cooperative agreements to appropriate public and 
     nonprofit private health or educational entities,

[[Page H9199]]

     including health professions schools and programs as defined 
     in section 799B, for the purpose of providing low-interest 
     loans, partial scholarships, partial fellowships, revolving 
     loan funds, or other cost-sharing forms of assistance for the 
     education and training of individuals in any category of 
     health professions for which there is a shortage that the 
     Secretary determines should be alleviated in order to prepare 
     for or respond effectively to bioterrorism and other public 
     health emergencies.
       ``(b) Authority Regarding Non-Federal Contributions.--The 
     Secretary may require as a condition of an award under 
     subsection (a) that a grantee under such subsection provide 
     non-Federal contributions toward the purpose described in 
     such subsection.
       ``(c) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 2002 through 2006.''.

     SEC. 107. EMERGENCY SYSTEM FOR VERIFICATION OF CREDENTIALS OF 
                   HEALTH PROFESSIONS VOLUNTEERS.

       Part B of title III of the Public Health Service Act, as 
     amended by section 106 of this Act, is amended by inserting 
     after section 319H the following section:

     ``SEC. 319I. EMERGENCY SYSTEM FOR VERIFICATION OF HEALTH 
                   PROFESSIONS VOLUNTEERS.

       ``(a) In General.--The Secretary shall, directly or through 
     an award of a grant, contract, or cooperative agreement, 
     establish and maintain a system for verifying the 
     credentials, licenses, accreditations, and hospital 
     privileges of individuals, who during public health 
     emergencies volunteer to serve as health professionals 
     (referred to in this section as the `verification system'). 
     In carrying out the preceding sentence, the Secretary shall 
     provide for an electronic database for the verification 
     system.
       ``(b) Certain Criteria.--The Secretary shall establish 
     criteria regarding the verification system under subsection 
     (a), including provisions regarding the promptness and 
     efficiency of the system in collecting, storing, updating, 
     and disseminating information on the credentials, licenses, 
     accreditations, and hospital privileges of volunteers 
     described in subsection (a).
       ``(c) Advance Registration of Volunteers.--In order to 
     facilitate the availability of health professionals during a 
     public health emergency, the Secretary shall provide for the 
     advance registration with the system of health professionals 
     who are willing to serve as volunteers described in 
     subsection (a), and may carry out activities to encourage 
     health professionals to register with the system.
       ``(d) Other Assistance.--The Secretary may make grants and 
     provide technical assistance to States and other public or 
     nonprofit private entities for activities relating to the 
     verification system developed under subsection (a).
       ``(e) Coordination Among States.--The Secretary shall 
     encourage each State to provide legal authority during a 
     public health emergency for health professionals authorized 
     in another State to provide certain health services to 
     provide such health services in the State.
       ``(f) Rule of Construction.--This section may not be 
     construed as authorizing the Secretary to issue requirements 
     regarding the provision by the States of credentials, 
     licenses, accreditations, or hospital privileges.
       ``(g) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $2,000,000 for fiscal year 2002, and such sums 
     as may be necessary for each of the fiscal years 2003 through 
     2006.''.

     SEC. 108. ENHANCING PREPAREDNESS ACTIVITIES FOR BIOTERRORISM 
                   AND OTHER PUBLIC HEALTH EMERGENCIES.

       Section 319F of the Public Health Service Act (42 U.S.C. 
     247d-6) is amended--
       (1) by amending subsection (a) to read as follows:
       ``(a) Working Group on Preparedness for Acts of 
     Bioterrorism.--The Secretary, in coordination with the 
     Secretary of Defense, the Director of the Federal Emergency 
     Management Agency, the Attorney General, the Secretary of 
     Veterans Affairs, the Secretary of Agriculture, the Secretary 
     of Energy, and the Administrator of the Environmental 
     Protection Agency shall establish a joint interdepartmental 
     working group on preparedness and readiness for the medical 
     and public health effects of a bioterrorist attack on the 
     civilian population. Such joint working group shall--
       ``(1) coordinate and prioritize research on, and the 
     development of countermeasures against, pathogens likely to 
     be used in a bioterrorist attack on the civilian population;
       ``(2) facilitate the development, production, and 
     regulatory review of priority countermeasures (as defined in 
     subsection (h)(2)(C)) for a bioterrorist attack on the 
     civilian population;
       ``(3) coordinate research and development into equipment to 
     detect pathogens likely to be used in a bioterrorist attack 
     on the civilian population and protect against infection from 
     such pathogens;
       ``(4) develop shared standards for equipment to detect and 
     to protect against infection from pathogens likely to be used 
     in a bioterrorist attack on the civilian population; and
       ``(5) coordinate the development, maintenance, and 
     procedures for the release and distribution of strategic 
     reserves of vaccines, drugs, and medical supplies which may 
     be needed rapidly after a bioterrorist attack upon the 
     civilian population, including consideration of vulnerable 
     populations (such as children, the elderly, and individuals 
     with disabilities).'';
       (2) in subsection (b)(1), by striking ``The Secretary'' and 
     all that follows through ``shall establish'' and inserting 
     the following: ``The Secretary, in collaboration with the 
     Secretary of Defense, the Director of the Federal Emergency 
     Management Agency, the Attorney General, the Secretary of 
     Veterans Affairs, the Secretary of Agriculture, the Secretary 
     of Labor, and the Administrator of the Environmental 
     Protection Agency, shall establish'';
       (3) in subsection (b)(2)--
       (A) in subparagraph (A), by striking ``respond to a 
     bioterrorist attack; and'' and inserting the following: 
     ``respond to a bioterrorist attack, including the provision 
     of appropriate safety and health training and protective 
     measures for medical, emergency service, and other personnel 
     responding to such attacks;'';
       (B) in subparagraph (B), by striking the period and 
     inserting ``; and''; and
       (C) by adding at the end the following subparagraph:
       ``(C) subject to compliance with other provisions of 
     Federal law, clarify the responsibilities among Federal 
     officials for the investigation of suspicious outbreaks of 
     disease, and revise the interagency plan known as the Federal 
     response plan accordingly.'';
       (4) in subsection (b)(3), by striking ``Assistant Secretary 
     for Health'' and inserting ``Assistant Secretary for 
     Emergency Preparedness''; and
       (5) in subsection (e) (as redesignated by section 104(1) of 
     this Act)--
       (A) in paragraph (1), by striking ``The Secretary'' and all 
     that follows and inserting the following: ``In consultation 
     with the working group established under subsection (b), the 
     Secretary shall, based on criteria established by the 
     Secretary, award grants to or enter into cooperative 
     agreements with eligible entities to increase their capacity 
     to detect, diagnose, and respond to acts of bioterrorism upon 
     the civilian population.'';
       (B) in paragraph (2)--
       (i) by striking ``or'' after ``clinic,''; and
       (ii) by inserting before the period the following: ``, 
     professional organizations and societies, schools or programs 
     that train medical laboratory personnel, private accrediting 
     organizations, or other nonprofit institutions or entities 
     meeting criteria established by the Secretary'';
       (C) in paragraph (3)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``the priorities'' and inserting ``any priorities''; and
       (ii) by striking subparagraphs (A) through (D) and 
     inserting the following:
       ``(A) developing community-wide plans involving the public 
     and private health care infrastructure to respond to 
     bioterrorism or other public health emergencies, which are 
     coordinated with the capacities of applicable national, 
     State, and local health agencies;
       ``(B) training health care professionals and public health 
     personnel to enhance the ability of such personnel to 
     recognize the symptoms and epidemiological characteristics of 
     exposure to a potential bioweapon, or other agents that may 
     cause a public health emergency;
       ``(C) addressing rapid and accurate identification of 
     potential bioweapons, or other agents that may cause a public 
     health emergency;
       ``(D) coordinating medical care for individuals during 
     public health emergencies, including bioterrorism;
       ``(E) conducting exercises to test the capability and 
     timeliness of public health emergency response activities;
       ``(F) facilitating and coordinating rapid communication of 
     data generated from a bioterrorist attack or public health 
     emergency among national, State, and local health agencies, 
     emergency response personnel, and health care providers and 
     facilities; and
       ``(G) purchasing or upgrading equipment, supplies, 
     pharmaceuticals or other countermeasures to enhance 
     preparedness for and response to bioterrorism or other public 
     health emergencies, consistent with a plan described in 
     subparagraph (A).''; and
       (D) in paragraph (4)--
       (i) in subparagraph (A), by striking ``and'' after the 
     semicolon at the end;
       (ii) in subparagraph (B), by striking the period at the end 
     and inserting ``; and''; and
       (iii) by adding at the end the following subparagraph:
       ``(C) coordinate grants under this subsection with grants 
     under 319C.''.

     SEC. 109. IMPROVING STATE AND LOCAL CORE PUBLIC HEALTH 
                   CAPACITIES.

       Section 319C of the Public Health Service Act (42 U.S.C. 
     247d-3) is amended--
       (1) in subsection (a), by striking ``competitive ''; and
       (2) in subsection (c)--
       (A) in paragraph (3), by striking ``health care providers; 
     and'' and inserting ``health care providers, including poison 
     control centers;'';
       (B) by redesignating paragraph (4) as paragraph (7); and
       (C) by inserting after paragraph (3) the following 
     paragraphs:
       ``(4) purchase or upgrade equipment, supplies, 
     pharmaceuticals or other countermeasures to enhance 
     preparedness for and response to bioterrorism or other public 
     health emergencies, consistent with a plan described in 
     paragraph (3);

[[Page H9200]]

       ``(5) conduct exercises to test the capability and 
     timeliness of public health emergency response activities;
       ``(6) within the meaning of part B of title XII, develop 
     and implement the trauma care component of the State plan for 
     the provision of emergency medical services; and'';

     SEC. 110. ANTIMICROBIAL RESISTANCE PROGRAM.

       Section 319E of the Public Health Service Act (42 U.S.C. 
     247d-5) is amended--
       (1) in subsection (b)--
       (A) by striking ``shall conduct and support'' and inserting 
     ``shall directly or through awards of grants or cooperative 
     agreements to public or private entities provide for the 
     conduct of''; and
       (B) by amending paragraph (4) to read as follows:
       ``(4) the sequencing of the genomes, or other appropriate 
     DNA analysis, or other necessary comparative analysis, of 
     priority pathogens (as determined by the Director of the 
     National Institutes of Health in consultation with the task 
     force established under subsection (a)), in collaboration and 
     coordination with the activities of the Department of Defense 
     and the Joint Genome Institute of the Department of Energy; 
     and'';
       (2) in subsection (e)(2), by inserting after ``societies,'' 
     the following: ``schools or programs that train medical 
     laboratory personnel,''; and
       (3) in subsection (g), by striking ``and such sums'' and 
     all that follows and inserting the following: ``$25,000,000 
     for each of the fiscal years 2002 and 2003, and such sums as 
     may be necessary for each of the fiscal years 2004 through 
     2006.''.

     SEC. 111. STUDY REGARDING COMMUNICATIONS ABILITIES OF PUBLIC 
                   HEALTH AGENCIES.

       The Secretary of Health and Human Services, in consultation 
     with the Federal Communications Commission, the National 
     Telecommunications and Information Administration, and other 
     appropriate Federal agencies, shall conduct a study to ensure 
     that local public health entities have the ability to 
     maintain communications in the event of a bioterrorist attack 
     or other public health emergency. The study shall examine 
     whether redundancies are required in the telecommunications 
     system for public health entities to maintain systems 
     operability and connectivity during such emergencies. The 
     study shall also include recommendations to industry and 
     public health entities about how to implement such 
     redundancies if necessary.

     SEC. 112. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.

       Part B of title III of the Public Health Service Act, as 
     amended by section 107 of this Act, is amended by inserting 
     after section 319I the following section:

     ``SEC. 319J. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS

       ``(a) In General.--Upon the request of a recipient of an 
     award under any of sections 319 through 319I or section 319K, 
     the Secretary may, subject to subsection (b), provide 
     supplies, equipment, and services for the purpose of aiding 
     the recipient in carrying out the purposes for which the 
     award is made and, for such purposes, may detail to the 
     recipient any officer or employee of the Department of Health 
     and Human Services.
       ``(b) Corresponding Reduction in Payments.--With respect to 
     a request described in subsection (a), the Secretary shall 
     reduce the amount of payments under the award involved by an 
     amount equal to the costs of detailing personnel and the fair 
     market value of any supplies, equipment, or services provided 
     by the Secretary. The Secretary shall, for the payment of 
     expenses incurred in complying with such request, expend the 
     amounts withheld.''.

     SEC. 113. ADDITIONAL AMENDMENTS.

       Part B of title III of the Public Health Service Act (42 
     U.S.C. 243 et seq) is amended--
       (1) in section 319A(a)(1), by striking ``10 years'' and 
     inserting ``five years''; and
       (2) in section 319B(a), in the first sentence, by striking 
     ``10 years'' and inserting ``five years''.

     SEC. 114. STUDY REGARDING LOCAL EMERGENCY RESPONSE METHODS.

       The Secretary of Health and Human Services shall conduct a 
     study of best-practices methods for the provision of 
     emergency response services through local governments 
     (including through contractors and volunteers of such 
     governments) in a consistent manner in response to acts of 
     bioterrorism or other public health emergencies. Not later 
     than 180 days after the date of the enactment of this Act, 
     the Secretary shall submit to the Congress a report 
     describing the findings of the study.

Subtitle B--National Stockpile; Development of Priority Countermeasures

     SEC. 121. NATIONAL STOCKPILE.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     maintain a stockpile or stockpiles of drugs, vaccines and 
     other biological products, medical devices, and other 
     supplies in such numbers, types, and amounts as are 
     determined by the Secretary to be adequate to meet the health 
     security needs of the United States, including consideration 
     of vulnerable populations (such as children, the elderly, and 
     individuals with disabilities), in the event of a 
     bioterrorist attack or other public health emergency.
       (b) Procedures.--The Secretary, in managing the stockpile 
     under subsection (a), shall--
       (1) consult with the Director of the Federal Emergency 
     Management Agency, the Secretary of Defense, the Secretary of 
     Veterans Affairs, the Attorney General, the Secretary of 
     Energy, and the Administrator of the Environmental Protection 
     Agency;
       (2) ensure that adequate procedures are followed with 
     respect to such stockpile for inventory management and 
     accounting, and for the physical security of the stockpile;
       (3) in consultation with Federal, State, and local 
     officials, take into consideration the timing and location of 
     special events;
       (4) review and revise, as appropriate, the contents of the 
     stockpile on a regular basis to ensure that emerging threats, 
     advanced technologies, and new countermeasures are adequately 
     considered; and
       (5) devise plans for the effective and timely distribution 
     of the stockpile, in consultation with appropriate Federal, 
     State and local agencies, and the public and private health 
     care infrastructure.
       (c) Definition.--For purposes of subsection (a), the term 
     ``stockpile'' includes--
       (1) a physical accumulation (at one or more locations) of 
     the supplies described in subsection (a); or
       (2) a contractual agreement between the Secretary and a 
     vendor or vendors under which such vendor or vendors agree to 
     provide to the Secretary supplies described in subsection 
     (a).
       (d) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $1,155,000,000 for fiscal year 2002, and such 
     sums as may be necessary for each of fiscal years 2003 
     through 2006.

     SEC. 122. ACCELERATED APPROVAL OF PRIORITY COUNTERMEASURES.

       (a) In General.--The Secretary of Health and Human Services 
     may designate a priority countermeasure as a fast-track 
     product pursuant to section 506 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 356). Such a designation may be 
     made prior to the submission of--
       (1) a request for designation by the sponsor; or
       (2) an application for the investigation of the drug under 
     section 505(i) of such Act or section 351(a)(3) of the Public 
     Health Service Act. Nothing in this subsection shall be 
     construed to prohibit a sponsor from declining such a 
     designation.
       (b) Review of Priority Countermeasure Not Designated as 
     Fast-Track Product.--A priority countermeasure shall be 
     subject to the performance goals established by the 
     Commissioner of Food and Drugs, unless it is designated as a 
     fast-track product.
       (c) Definition.--For purposes of this section, the term 
     ``priority countermeasure'' means a drug or biological 
     product that is a countermeasure to treat, identify, or 
     prevent infection by a biological agent or toxin listed 
     pursuant to section 351A(a)(1) or harm from any other agent 
     that may cause a public health emergency.

     SEC. 123. USE OF ANIMAL TRIALS IN APPROVAL OF CERTAIN DRUGS 
                   AND BIOLOGICS; ISSUANCE OF RULE.

       Not later than 180 days after the date of the enactment of 
     this Act, the Secretary of Health and Human Services shall 
     complete the process of rulemaking that was commenced with 
     the issuance of the proposed rule entitled ``New Drug and 
     Biological Drug Products; Evidence Needed to Demonstrate 
     Efficacy of New Drugs for Use Against Lethal or Permanently 
     Disabling Toxic Substances When Efficacy Studies in Humans 
     Ethically Cannot be Conducted'' published in the Federal 
     Register on October 5, 1999 (64 Fed. Reg. 53960).

     SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND 
                   PRODUCTION.

       Part B of title III of the Public Health Service Act, as 
     amended by section 112 of this Act, is amended by inserting 
     after section 319J the following section:

     ``SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND 
                   PRODUCTION.

       ``The Secretary, in consultation with the Attorney General 
     and the Secretary of Defense, may provide technical or other 
     assistance to provide security to persons or facilities that 
     conduct development, production, distribution, or storage of 
     priority countermeasures (as defined in section 
     319F(h)(2)(C)).''.

     SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND 
                   DEVELOPMENT.

       Section 319F(h) of the Public Health Service Act, as 
     redesignated by section 104(1) of this Act, is amended--
       (1) by redesignating paragraphs (1) through (4), as 
     subparagraphs (A) through (D), respectively;
       (2) by striking ``The Secretary'' and inserting the 
     following:
       ``(1) In general.--The Secretary'';
       (3) by moving each of subparagraphs (A) through (D) (as so 
     redesignated) two ems to the right; and
       (4) by adding at the end the following:
       ``(2) Accelerated countermeasure research and 
     development.--
       ``(A) In general.--With respect to pathogens of potential 
     use in a bioterrorist attack, and other agents that may cause 
     a public health emergency, the Secretary, taking into 
     consideration any recommendations of the working group under 
     subsection (a), shall conduct, and award grants, contracts, 
     or cooperative agreements for, research, investigations, 
     experiments, demonstrations, and studies in the health 
     sciences relating to--
       ``(i) the epidemiology and pathogenesis of such pathogens;

[[Page H9201]]

       ``(ii) the development of new vaccines and therapeutics for 
     use against such pathogens and other agents;
       ``(iii) the development of diagnostic tests to detect such 
     pathogens and other agents; and
       ``(iv) other relevant areas of research;
     with consideration given to the needs of children and other 
     vulnerable populations.
       ``(B) Role of department of veterans affairs.--In carrying 
     out subparagraph (A), the Secretary shall consider using the 
     biomedical research and development capabilities of the 
     Department of Veterans Affairs, in conjunction with that 
     Department's affiliations with health-professions 
     universities. When advantageous to the Government in 
     furtherance of the purposes of such subparagraph, the 
     Secretary may enter into cooperative agreements with the 
     Secretary of Veterans Affairs to achieve such purposes.
       ``(C) Priority countermeasures.--For purposes of this 
     paragraph, the term `priority countermeasure' means a 
     countermeasure, including a drug, medical or other 
     technological device, biological product, or diagnostic test, 
     to treat, identify, or prevent infection by a biological 
     agent or toxin listed pursuant to section 351A(a)(1) or harm 
     from any other agent that may cause a public health 
     emergency.''.

     SEC. 126. EVALUATION OF NEW AND EMERGING TECHNOLOGIES 
                   REGARDING BIOTERRORIST ATTACK AND OTHER PUBLIC 
                   HEALTH EMERGENCIES.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     promptly carry out a program to evaluate new and emerging 
     technologies that are designed to improve or enhance the 
     ability of public health or safety officials to detect, 
     identify, diagnose, or conduct public health surveillance 
     activities relating to a bioterrorist attack or other public 
     health emergency.
       (b) Certain Activities.--In carrying out this subsection, 
     the Secretary shall--
       (1) survey existing technology programs funded by the 
     Federal Government for potentially useful technologies;
       (2) promptly issue a request for information from non-
     Federal public and private entities for ongoing activities in 
     this area; and
       (3) evaluate technologies identified under paragraphs (1) 
     and (2) pursuant to subsection (c).
       (c) Consultation and Evaluation.--In carrying out 
     subsection (b)(3), the Secretary shall consult with the joint 
     interdepartmental working group under section 319F(a) of the 
     Public Health Service Act, as well as other appropriate 
     public, nonprofit, and private entities, to develop criteria 
     for the evaluation of such technologies and to conduct such 
     evaluations.
       (d) Report.--Not later than 180 days after the date of the 
     enactment of this Act, the Secretary shall submit to the 
     Committee on Energy and Commerce of the House of 
     Representatives, and the Committee on Health, Education, 
     Labor, and Pensions of the Senate, a report that provides a 
     list of priority technologies whose development or deployment 
     or both should be accelerated, and the estimated cost of 
     doing so.

     SEC. 127. POTASSIUM IODIDE.

       (a) In General.--Through the national stockpile under 
     section 121, the Secretary of Health and Human Services (in 
     this section referred to as the ``Secretary''), subject to 
     subsection (b), shall make available to State and local 
     governments potassium iodide tablets for stockpiling and for 
     distribution as appropriate to public facilities, such as 
     schools and hospitals, that are within 20 miles of a nuclear 
     power plant, in quantities sufficient to provide adequate 
     protection for the populations within such miles.
       (b) State and Local Plans.--Subsection (a) applies with 
     respect to a State or local government if the government 
     involved meets the following conditions:
       (1) Such government submits to the Secretary, and to the 
     Director of the Federal Emergency Management Agency, a plan 
     for the stockpiling of potassium iodide tablets, and for the 
     distribution and utilization of potassium iodide tablets in 
     the event of a nuclear incident.
       (2) The plan is accompanied by certifications by such 
     government that--
       (A) the government has not received sufficient quantities 
     of potassium iodide tablets from the Nuclear Regulatory 
     Commission; and
       (B) in the case of a local government, such government has 
     submitted the plan to the State involved.
       (c)  Guidelines.--In consultation with the Director of the 
     Federal Emergency Management Agency and with the Nuclear 
     Regulatory Commission, the Secretary shall establish 
     guidelines for the stockpiling of potassium iodide tablets, 
     and for the distribution and utilization of potassium iodide 
     tablets in the event of a nuclear incident.
       (d) Information.--The Secretary shall carry out activities 
     to inform State and local governments of the program under 
     this section.
       (e) Report.--Not later than six months after the date of 
     the enactment of this Act, the Secretary shall submit to the 
     Congress a report--
       (1) on whether potassium iodide tablets have been made 
     available under subsection (a) and the extent to which State 
     and local governments have established stockpiles of such 
     tablets; and
       (2) the measures taken by the Secretary to implement this 
     section.
       (f) Applicability.--Subsections (a) and (d) cease to apply 
     as requirements if the Secretary determines that there is an 
     alternative and more effective medical treatment to address 
     adverse thyroid conditions that may result from the release 
     of radionuclides from nuclear power plants.

        Subtitle C--Emergency Authorities; Additional Provisions

     SEC. 131. EXPANDED AUTHORITY OF SECRETARY OF HEALTH AND HUMAN 
                   SERVICES TO RESPOND TO PUBLIC HEALTH 
                   EMERGENCIES.

       (a) Transfers of Funds.--Section 319 of the Public Health 
     Service Act (42 U.S.C. 247d) is amended by adding at the end 
     the following:
       ``(d) Transfers of Funds Between Programs and Accounts.--
       ``(1) In general.--At any time during a public health 
     emergency declared by the Secretary under subsection (a), the 
     Secretary may, subject to paragraph (2), transfer funds, to 
     the extent authorized by law, between appropriations accounts 
     administered by the Secretary under this Act, without regard 
     to any waiting period imposed by any other provision of law, 
     including any provision of an appropriations Act, except as 
     provided in paragraphs (3) and (4).
       ``(2) Amount of transfers.--With respect to the public 
     health emergency involved:
       ``(A) The Secretary may not make a transfer under paragraph 
     (1) in an amount exceeding a reasonable estimate by the 
     Secretary of the amount necessary to respond to the emergency 
     involved for a period of 60 days.
       ``(B) Subsequent transfers under paragraph (1) may be made 
     by the Secretary, subject to compliance with subparagraph 
     (A).
       ``(3) Notification.--Not later than 48 hours prior to 
     making a transfer under paragraph (1), the Secretary shall 
     submit a notice of the intent to make such transfer to the 
     Committee on Appropriations of the House of Representatives, 
     the Committee on Energy and Commerce of the House of 
     Representatives, the Committee on Appropriations of the 
     Senate, and the Committee on Health, Education, Labor, and 
     Pensions of the Senate.
       ``(4) Scope.--Paragraph (1) shall apply, notwithstanding 
     any other provision of law including any provision of an 
     appropriations Act and any Act enacted after the date of 
     enactment of this subsection, unless such provision 
     specifically refers to and overrides this subsection.''.
        (b) Reporting Deadlines.--Section 319 of the Public Health 
     Service Act (42 U.S.C. 247d), as amended by subsection (a), 
     is further amended by adding at the end the following:
       ``(e) Data Submittal and Reporting Deadlines.--In any case 
     in which the Secretary determines that, wholly or partially 
     as a result of a public health emergency that has been 
     declared pursuant to subsection (a), individuals or public or 
     private entities are unable to comply with deadlines for the 
     submission to the Secretary of data or reports required under 
     any law administered by the Secretary, the Secretary may, 
     notwithstanding any other provision of law, grant such 
     extensions of such deadlines as the circumstances reasonably 
     require, and may waive, wholly or partially, any sanctions 
     otherwise applicable to such failure to comply. Before or 
     promptly after granting such an extension or waiver, the 
     Secretary shall notify the Congress of such action and 
     publish in the Federal Register a notice of the extension or 
     waiver.''.

     SEC. 132. STREAMLINING AND CLARIFYING COMMUNICABLE DISEASE 
                   QUARANTINE PROVISIONS.

       (a) Elimination of Prerequisite for National Advisory 
     Health Council Recommendation Before Issuing Quarantine 
     Rules.--
       (1) Executive orders specifying diseases subject to 
     individual detentions.--Section 361(b) of the Public Health 
     Act (42 U.S.C. 264(b)) is amended by striking ``Executive 
     orders of the President upon the recommendation of the 
     National Advisory Health Council and the Surgeon General'' 
     and inserting ``Executive orders of the President upon the 
     recommendation of the Secretary, in consultation with the 
     Surgeon General,''.
       (2) Regulations providing for apprehension of 
     individuals.--Section 361(d) of the Public Health Act (42 
     U.S.C. 264(d)) is amended by striking ``On recommendation of 
     the National Advisory Health Council, regulations'' and 
     inserting ``Regulations''.
       (3) Regulations providing for apprehension of individuals 
     in wartime.--Section 363 of the Public Health Act (42 U.S.C. 
     266) is amended by striking ``the Surgeon General, on 
     recommendation of the National Advisory Health Council,'' and 
     inserting ``the Secretary, in consultation with the Surgeon 
     General,''.
       (b) Apprehension Authority To Apply in Cases of Exposure to 
     Disease.--
       (1) Regulations providing for apprehension of 
     individuals.--Section 361(d) of the Public Health Act (42 
     U.S.C. 264(d)), as amended by subsection (a)(2), is further 
     amended by inserting ``or exposed to'' after ``to be infected 
     with''.
       (2) Regulations providing for apprehension of individuals 
     in wartime.--Section 363 of the Public Health Act (42 U.S.C. 
     266), as amended by subsection (a)(3), is further amended by 
     inserting ``or exposed to'' after ``to be infected with''.
       (c) State Authority.--Section 361 of the Public Health Act 
     (42 U.S.C. 264) is amended by adding at the end the 
     following:
       ``(e) Nothing in this section or section 363, or the 
     regulations promulgated under such

[[Page H9202]]

     sections, may be construed as superseding any provision under 
     State law (including regulations and including provisions 
     established by political subdivisions of States), except to 
     the extent that such a provision conflicts with an exercise 
     of Federal authority under this section or section 363.''.

     SEC. 133. EMERGENCY WAIVER OF MEDICARE, MEDICAID, AND SCHIP 
                   REQUIREMENTS.

       (a) Waiver Authority.--Title XI of the Social Security Act 
     (42 U.S.C. 1301 et seq.) is amended by inserting after 
     section 1134 the following new section:

     ``SEC. 1135. AUTHORITY TO WAIVE REQUIREMENTS DURING NATIONAL 
                   EMERGENCIES.

       ``(a) Purpose.--
       ``(1) In general.--The purpose of this section is to enable 
     the Secretary to ensure to the maximum extent feasible, in 
     any emergency area and during an emergency period--
       ``(A) that sufficient health care items and services are 
     available to meet the needs of individuals in such area 
     enrolled in the programs under titles XVIII, XIX, and XXI; 
     and
       ``(B) that health care providers (as defined in subsection 
     (g)) that furnish such items and services in good faith, but 
     that are unable to comply with one or more requirements 
     described in subsection (b), may be reimbursed for such items 
     and services and exempted from sanctions for such 
     noncompliance, absent any determination of fraud or abuse.
       ``(2) Emergency area; emergency period.--For purposes of 
     this section, an `emergency area' is a geographical area in 
     which, and an `emergency period' is the period during which, 
     there exists--
       ``(A) an emergency or disaster declared by the President 
     pursuant to the National Emergencies Act or the Robert T. 
     Stafford Disaster Relief and Emergency Assistance Act; and
       ``(B) a public health emergency declared by the Secretary 
     pursuant to section 319 of the Public Health Service Act.
       ``(b) Secretarial Authority.--To the extent necessary to 
     accomplish the purposes specified in subsection (a), the 
     Secretary is authorized, subject to the provisions of this 
     section, to temporarily waive or modify the application of, 
     with respect to health care items and services furnished in 
     any emergency area (or portion of such an area) during an 
     emergency period, the requirements of titles XVIII, XIX, or 
     XXI, or any regulation thereunder (and the requirements of 
     this title, and regulations thereunder, insofar as they 
     relate to such titles), pertaining to--
       ``(1) conditions of participation or other certification 
     requirements for an individual health care provider or types 
     of providers; program participation and similar requirements 
     for an individual health care provider or types of providers; 
     and pre-approval requirements;
       ``(2) requirements that physicians and other health care 
     professionals be licensed in the State in which they provide 
     such services, if they have equivalent licensing in another 
     State;
       ``(3) sanctions under section 1867 (relating to examination 
     and treatment for emergency medical conditions and women in 
     labor) for a transfer of an individual who has not been 
     stabilized in violation of subsection (c) of such section if 
     the transfer arises out of the circumstances of the 
     emergency;
       ``(4) sanctions under section 1877(g) (relating to 
     limitations on physician referral); and
       ``(5) deadlines and timetables for performance of required 
     activities, except that such deadlines and timetables may 
     only be modified, not waived.
       ``(c) Authority for Retroactive Waiver.--A waiver or 
     modification of requirements pursuant to this section may, at 
     the Secretary's discretion, be made retroactive to the 
     beginning of the emergency period or any subsequent date in 
     such period specified by the Secretary.
       ``(d) Notification of Congress.--The Secretary shall 
     provide advance written notice to the Congress at least two 
     days before exercising the authority under this section with 
     respect to an emergency area. Such a notice shall include a 
     description of the specific provisions that will be waived or 
     modified, the health care providers to whom the waiver or 
     modification will apply, the geographic area in which the 
     waiver or modification will apply, and the period of time for 
     which the waiver or modification will be in effect.
       ``(e) Duration of Waiver.--
       ``(1) In general.--A waiver or modification of requirements 
     pursuant to this section terminates upon--
       ``(A) the termination of the applicable declaration of 
     emergency or disaster described in subsection (a)(2)(B);
       ``(B) the termination of the applicable declaration of 
     public health emergency described in subsection (a)(2)(B); or
       ``(C) subject to paragraph (2), the termination of a period 
     of 90 days from the date the waiver or modification is first 
     published (or, if applicable, the date of extension of the 
     waiver or modification under paragraph (2)).
       ``(2) Extension of 90-day periods.--The Secretary may, by 
     notice, provide for an extension of a 90-day period described 
     in paragraph (1)(C) (or an additional period provided under 
     this paragraph) for additional period or periods (not to 
     exceed, except as subsequently provided under this paragraph, 
     90 days each), but any such extension shall not affect or 
     prevent the termination of a waiver or modification under 
     subparagraph (A) or (B) of paragraph (1).
       ``(f) Report to Congress.--Within one year after the end of 
     the emergency period in an emergency area in which the 
     Secretary exercised the authority provided under this 
     section, the Secretary shall report to the Congress regarding 
     the approaches used to accomplish the purposes described in 
     subsection (a), including an evaluation of the success of 
     such approaches and recommendations for improved approaches 
     should the need for such emergency authority arise in the 
     future.
       ``(g) Health Care Provider Defined.--For purposes of this 
     section, the term `health care provider' means any entity 
     that furnishes health care items or services, and includes a 
     hospital or other provider of services, a physician or other 
     health care practitioner or professional, a health care 
     facility, or a supplier of health care items or services.''.
       (b) Effective Date.--The amendments made by subsection (a) 
     shall be effective on and after September 11, 2001.

     SEC. 134. PROVISION FOR EXPIRATION OF PUBLIC HEALTH 
                   EMERGENCIES.

       Section 319(a) of the Public Health Service Act (42 U.S.C. 
     247d(a)), is amended by adding at the end the following new 
     sentence: ``Any such determination of a public health 
     emergency terminates upon the Secretary declaring that the 
     emergency no longer exists, or upon the expiration of the 90-
     day period beginning on the date on which the determination 
     is made by the Secretary, whichever occurs first. 
     Determinations that terminate under the preceding sentence 
     may be renewed by the Secretary (on the basis of the same or 
     additional facts), and the preceding sentence applies to each 
     such renewal.''.

     SEC. 135. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT 
                   PLAN.

       Section 613(b) of the Robert T. Stafford Disaster Relief 
     and Emergency Assistance Act (42 U.S.C. 5196b(b)) is 
     amended--
       (1) in paragraph (5), by striking ``and'' at the end;
       (2) in paragraph (6), by striking the period and inserting 
     ``; and''; and
       (3) by adding at the end the following:
       ``(7) include a plan for providing information to the 
     public in a coordinated manner.''.

     SEC. 136. EXPANDED RESEARCH BY SECRETARY OF ENERGY.

       (a) In General.--In coordination with the joint 
     interdepartmental working group under section 319F(a) of the 
     Public Health Service Act, the Secretary of Energy and the 
     Administrator of the National Nuclear Security Administration 
     shall expand, enhance, and intensify research relevant to the 
     rapid detection and identification of pathogens likely to be 
     used in a bioterrorism attack or other agents that may cause 
     a public health emergency.
       (b) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section such sums as may 
     be necessary for each of the fiscal years 2002 through 2006.

     SEC. 137. AGENCY FOR TOXIC SUBSTANCE AND DISEASE REGISTRY.

       (a) In General.--In planning for and responding to 
     bioterrorism and other public health emergencies, including 
     assisting State health departments, the Secretary of Health 
     and Human Services (in this section referred to as the 
     ``Secretary'') shall take into account the role and expertise 
     of the Agency for Toxic Substances and Disease Registry (in 
     this section referred to as ``ATSDR'').
       (b) Authorization of Appropriations.--For the purpose of 
     providing resources (including increased personnel, as 
     appropriate) for ATSDR to use authorities under section 
     104(i) of the Comprehensive Environmental Response, 
     Compensation, and Liability Act of 1980 to assist the 
     Secretary in planning for or responding to bioterrorism or 
     other public health emergencies, there are authorized to be 
     appropriated to the Secretary such sums as may be necessary 
     for each of the fiscal years 2002 through 2006, in addition 
     to any other authorizations of appropriations that are 
     available for such purpose.

     SEC. 138. EXPANDED RESEARCH ON WORKER HEALTH AND SAFETY.

       The Secretary, acting through the Director of the National 
     Institute of Occupational Safety and Health, shall enhance 
     and expand research as deemed appropriate on the health and 
     safety of workers who are at risk for bioterrorist threats or 
     attacks in the workplace.

     SEC. 139. TECHNOLOGY OPPORTUNITIES PROGRAM SUPPORT.

        For fiscal years 2003 and 2004, all of the information 
     infrastructure grants provided by the National 
     Telecommunications and Information Administration (under the 
     program also known as the Technology Opportunities Program) 
     shall be used to provide grants to health providers to 
     facilitate participation in the national public health 
     communications and surveillance networks authorized under 
     section 319D(b)(3) of the Public Health Service Act.

              Subtitle D--Authorization of Appropriations

     SEC. 151. AUTHORIZATION OF APPROPRIATIONS.

       (a) In General.--For the purpose of carrying out activities 
     of the Department of Health and Human Services in accordance 
     with the provisions referred to in subsection (b), including 
     making awards of grants, cooperative agreements, or contracts 
     and providing other assistance to States and other public or 
     private entities, there are authorized to be appropriated 
     $2,720,000,000 for fiscal year 2002, and such sums as may be 
     necessary for each of the fiscal years 2003 through 2006.
       (b) Relevant Provisions.--For purposes of this section, the 
     provisions referred to in this subsection are--

[[Page H9203]]

       (1) the provisions of this title;
       (2) sections 319A through 319K of the Public Health Service 
     Act;
       (3) title XXVIII of such Act; and
       (4) section 301 of such Act, to the extent that such 
     section is used as the authority of the Secretary of Health 
     and Human Services to carry out activities to supplement the 
     activities carried out under the provisions referred to in 
     paragraphs (1) through (3);
     except that this section does not have any applicability with 
     respect to the use of section 301 of such Act as authority 
     for activities of the National Institutes of Health.
       (c) Fiscal Year 2002.--
       (1) In general.--The aggregate amount of authorizations of 
     appropriations under this title and under the Public Health 
     Service Act for fiscal year 2002 for the purpose described in 
     subsection (a) does not exceed the amount specified for 
     fiscal year 2002 in such subsection, notwithstanding other 
     authorizations of appropriations.
       (2) Allocations of authorizations.--Of the amount that is 
     authorized to be appropriated under subsection (a) for fiscal 
     year 2002, the following authorizations of appropriations for 
     such fiscal year for the purpose described in such subsection 
     apply:
       (A) For making awards of grants, cooperative agreements, or 
     contracts and providing other assistance to States and other 
     public or private entities, $1,000,000,000 is authorized, of 
     which--
       (i) $455,000,000 is authorized for grants under section 
     319C of the Public Health Service Act;
       (ii) $455,000,000 is authorized for grants or cooperative 
     agreements under section 319F of such Act; and
       (iii) $40,000,000 is authorized for grants or cooperative 
     agreements under section 319H of the Public Health Service 
     Act, as added by section 106 of this Act (relating to 
     shortages of certain health professionals).
       (B) For the national stockpile under section 121 of this 
     Act, other than activities of the National Institutes of 
     Health regarding smallpox vaccine, $1,155,000,000 is 
     authorized, of which $509,000,0000 is authorized for the 
     acquisition of smallpox vaccine.
       (C) For the Centers for Disease Control and Prevention, 
     other than purposes to which the authorization established in 
     subparagraph (A) applies, $450,000,000, of which $300,000,000 
     is authorized for facilities of such Centers for purposes 
     described in section 399D(c) of the Public Health Service 
     Act.
       (D) For activities on antimicrobial resistance under 
     section 319E of such Act, $25,000,000 is authorized.

 TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS

     SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.

       (a) Biological Agents Provisions of the Antiterrorism and 
     Effective Death Penalty Act of 1996; Codification in the 
     Public Health Service Act, With Amendments.--
       (1) Public health service act.--Subpart 1 of part F of 
     title III of the Public Health Service Act (42 U.S.C. 262 et 
     seq.) is amended by inserting after section 351 the 
     following:

     ``SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS 
                   AND TOXINS.

       ``(a) Regulatory Control of Certain Biological Agents and 
     Toxins.--
       ``(1) List of biological agents and toxins.--
       ``(A) In general.--The Secretary shall by regulation 
     establish and maintain a list of each biological agent and 
     each toxin that has the potential to pose a severe threat to 
     public health and safety.
       ``(B) Criteria.--In determining whether to include an agent 
     or toxin on the list under subparagraph (A), the Secretary 
     shall--
       ``(i) consider--

       ``(I) the effect on human health of exposure to the agent 
     or toxin;
       ``(II) the degree of contagiousness of the agent or toxin 
     and the methods by which the agent or toxin is transferred to 
     humans;
       ``(III) the availability and effectiveness of immunizations 
     to prevent and treatments for any illness resulting from 
     infection by the agent or toxin; and
       ``(IV) any other criteria that the Secretary considers 
     appropriate; and

       ``(ii) consult with scientific experts representing 
     appropriate professional groups.
       ``(2) Biennial publication.--The Secretary shall publish 
     the list under paragraph (1) biennially, or at such more 
     frequent intervals as the Secretary determines to be 
     appropriate. Before publishing the list, the Secretary shall 
     review the list, and shall make such revisions as are 
     appropriate to protect the public health and safety. In 
     reviewing and revising the list, the Secretary shall consider 
     the needs of vulnerable populations, including children, and 
     shall consult with appropriate Federal agencies and State and 
     local public health officials.
       ``(b) Regulation of Transfers of Listed Biological Agents 
     and Toxins.--The Secretary shall by regulation provide for--
       ``(1) the establishment and enforcement of safety 
     procedures for the transfer of biological agents and toxins 
     listed pursuant to subsection (a)(1), including measures to 
     ensure--
       ``(A) proper training and appropriate skills to handle such 
     agents and toxins; and
       ``(B) proper laboratory facilities to contain and dispose 
     of such agents and toxins;
       ``(2) safeguards to prevent access to such agents and 
     toxins for use in domestic or international terrorism or for 
     any other criminal purpose;
       ``(3) the establishment of procedures to protect the public 
     safety in the event of a transfer or potential transfer of a 
     biological agent or toxin in violation of the safety 
     procedures established under paragraph (1) or the safeguards 
     established under paragraph (2); and
       ``(4) appropriate availability of biological agents and 
     toxins for research, education, and other legitimate 
     purposes.
       ``(c) Possession and Use of Listed Biological Agents and 
     Toxins.--The Secretary shall by regulation provide for the 
     establishment and enforcement of standards and procedures 
     governing the possession and use of biological agents and 
     toxins listed pursuant to subsection (a)(1) in order to 
     protect the public health and safety, including the measures, 
     safeguards, procedures, and availability of such agents and 
     toxins described in paragraphs (1) through (4) of subsection 
     (b), respectively.
       ``(d) Registration and Traceability Mechanisms; Database.--
     Regulations under subsections (b) and (c) shall require 
     registration of the possession, use, and transfer of 
     biological agents and toxins listed pursuant to subsection 
     (a)(1), and such registration shall include (if available to 
     the registered person) information regarding the 
     characterization of such biological agents and toxins to 
     facilitate their identification and traceability. The 
     Secretary shall maintain a national database of the location 
     of such agents and toxins, with information regarding their 
     characterizations.
       ``(e) Inspections.--The Secretary may conduct inspections 
     to ensure that persons subject to regulations under 
     subsection (b) or (c) are in compliance with such 
     regulations, including provisions regarding security and 
     restrictions on access under subsection (g).
       ``(f) Exemptions.--The Secretary may establish exemptions 
     from the applicability of provisions of regulations under 
     subsection (b) or (c) if the Secretary determines that such 
     exemptions are consistent with protecting the public health 
     and safety. In the case of a clinical laboratory that is in 
     possession of a biological agent or toxin listed pursuant to 
     subsection (a)(1), such an exemption may be provided only if 
     such agent or toxin has been presented for diagnosis, 
     verification, or proficiency testing, and upon identification 
     or verification of the agent or toxin, such laboratory--
       ``(1) promptly notifies the Secretary or other public 
     health authorities when required under Federal or State law; 
     and
       ``(2) transfers or destroys the agent or toxin in 
     accordance with such regulations.
       ``(g) Security Requirements for Registered Persons.--
       ``(1) In general.--In carrying out the provisions of 
     subsections (b) and (c) that relate to safeguards, the 
     Secretary, in consultation with the Attorney General, shall 
     by regulation establish appropriate security requirements for 
     persons possessing, using, or transferring biological agents 
     or toxins listed pursuant to subsection (a)(1), and ensure 
     compliance with such requirements as a condition of 
     registration under subsection (b) or (c).
       ``(2) Limiting access to listed agents and toxins.--
       ``(A) In general.--Regulations issued under subsections (b) 
     and (c) shall include provisions--
       ``(i) to restrict access to biological agents and toxins 
     listed pursuant to subsection (a)(1) to only those 
     individuals who have a legitimate need for access, as 
     determined according to the purposes for which the 
     registration under such regulations is provided; and
       ``(ii) to ensure that individuals granted such access are 
     not--

       ``(I) restricted persons, as defined in section 175b of 
     title 18, United States Code;
       ``(II) named in a warrant issued to a Federal or State law 
     enforcement agency for participation in any domestic or 
     international act of terrorism or other act of violence;
       ``(III) under investigation for involvement with a domestic 
     or international terrorist or criminal organization by any 
     Federal law enforcement or intelligence agency; or
       ``(IV) suspected by any Federal law enforcement or 
     intelligence agency of seeking to obtain covertly information 
     relating to biological agents or toxins on behalf of the 
     intelligence or military operations of a foreign nation.

       ``(B) Screening protocol.--To carry out subparagraph (A), 
     the Secretary shall require that registered persons promptly 
     submit the names and other identifying information for 
     individuals described in subparagraph (A)(i) to the Secretary 
     and the Attorney General, with which information the Attorney 
     General shall promptly use criminal, immigration, and 
     national security databases available to the Federal 
     Government to identify whether such individuals satisfy the 
     conditions for access under subparagraph (A)(ii). The 
     Secretary, in consultation with the Attorney General and 
     other Federal agencies, shall periodically review and as 
     appropriate revise the protocol for screening individuals for 
     purposes of subparagraph (A), and may require by regulation 
     additional screening measures if determined necessary to 
     achieve the purposes of this section.
       ``(3) Assistance for certain entities.--The Secretary, in 
     consultation with the Attorney General, may make awards of 
     grants, contracts, or cooperative agreements to public and 
     nonprofit private entities (other than Federal agencies), and 
     may provide technical assistance to such entities, to improve 
     security of the facilities of registered persons.

[[Page H9204]]

       ``(h) Disclosure of Information.--
       ``(1) In general.--Any information in the possession of any 
     Federal agency that identifies a person, or the geographic 
     location of a person, who is registered pursuant to 
     regulations under this section (including regulations 
     promulgated before the effective date of this subsection), 
     and any site-specific information relating to the type, 
     quantity, or identity of a biological agent or toxin listed 
     pursuant to subsection (a)(1) or the site-specific security 
     mechanisms in place to protect such agents and toxins, shall 
     not be disclosed under section 552(a) of title 5, United 
     States Code.
       ``(2) Disclosures for public health and safety; congress.--
     Nothing in this section may be construed as preventing the 
     head of any Federal agency--
       ``(A) from making disclosures of information described in 
     paragraph (1) for purposes of protecting the public health 
     and safety; or
       ``(B) from making disclosures of such information to any 
     committee or subcommittee of the Congress with appropriate 
     jurisdiction, upon request.
       ``(i) Civil Money Penalty.--
       ``(1) In general.--In addition to any other penalties that 
     may apply under law, any person who violates any provision of 
     regulations under subsection (b) or (c) shall be subject to 
     the United States for a civil money penalty in an amount not 
     exceeding $250,000 in the case of an individual and $500,000 
     in the case of any other person.
       ``(2) Applicability of certain provisions.--The provisions 
     of section 1128A of the Social Security Act (other than 
     subsections (a), (b), (h), and (i), the first sentence of 
     subsection (c), and paragraphs (1) and (2) of subsection (f)) 
     shall apply to a civil money penalty under paragraph (1) in 
     the same manner as such provisions apply to a penalty or 
     proceeding under section 1128A(a) of such Act. The Secretary 
     may delegate authority under this subsection in the same 
     manner as provided in section 1128A(j)(2) of the Social 
     Security Act, and such authority shall include all powers as 
     contained in section 6 of the Inspector General Act of 1978.
       ``(j) Coordination With Regulations Under Virus-Serum-Toxin 
     Act.--
       ``(1) In general.--In establishing and enforcing 
     regulations under subsections (b) and (c), the Secretary 
     shall consult with the Secretary of Agriculture to ensure 
     that such activities are coordinated, to the greatest extent 
     practicable, with regulations governing certain biological 
     agents and toxins listed pursuant to subsection (a)(1) issued 
     by the Secretary of Agriculture under the Act commonly known 
     as the Virus-Serum-Toxin Act (the eighth paragraph under the 
     heading `Bureau of Animal Industry' in the Act of March 4, 
     1913; 21 U.S.C. 151-159) (in this subsection referred to as 
     the `VST Act'). The purpose of such coordination shall be--
       ``(A) to minimize any conflicts between the regulations 
     issued by, or the activities of, the Secretary of Health and 
     Human Services and the Secretary of Agriculture with respect 
     to such agents and toxins;
       ``(B) to minimize the administrative burden on persons 
     subject to regulations under both this section and the VST 
     Act;
       ``(C) to ensure the appropriate availability of such agents 
     and toxins for legitimate agricultural or veterinary 
     research, education, or other such purposes; and
       ``(D) to ensure the establishment of a national database of 
     such agents or toxins pursuant to subsection (d).
       ``(2) Persons regulated by department of agriculture.--With 
     respect to persons possessing or using biological agents or 
     toxins listed pursuant to subsection (a)(1) who, as of the 
     date of enactment of the Public Health Security and 
     Bioterrorism Response Act of 2001, possess an unexpired, 
     unrevoked, and unsuspended permit or license from the 
     Department of Agriculture for such possession or use, such 
     persons may, for purposes of registration under subsection 
     (b) or (c), submit to the Secretary of Health and Human 
     Services the same information previously provided to the 
     Secretary of Agriculture to obtain such permit or license, 
     provided that the information so submitted is accurate as of 
     the time of submittal to the Secretary of Health and Human 
     Services, and provided further that such Secretary may, after 
     review of such submission, request such additional 
     information as the Secretary determines to be necessary to 
     achieve the purposes of this section.
       ``(3) Savings provision.--Nothing in this section shall be 
     construed as limiting any authority of the Secretary of 
     Agriculture under the VST Act or any regulations issued 
     thereunder.
       ``(k) Definitions.--For purposes of this section:
       ``(1) The terms `biological agent' and `toxin' have the 
     meanings given such terms in section 178 of title 18, United 
     States Code.
       ``(2) The term `registered person' means a person 
     registered under regulations under subsection (b) or (c).
       ``(l) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 2002 through 2006.''.
       (2) Relation to other laws.--
       (A) Rule of construction.--Regulations promulgated by the 
     Secretary of Health and Human Services under section 511 of 
     the Antiterrorism and Effective Death Penalty Act of 1996 are 
     deemed to have been promulgated under section 351A of the 
     Public Health Service Act, as added by paragraph (1) of this 
     subsection. Such regulations, including the list under 
     subsection (d)(1) of such section 511, that were in effect on 
     the day before the date of the enactment of this Act remain 
     in effect until modified by the Secretary (including any 
     revisions required under subsection (a)(2) of such section 
     351A).
       (B) Conforming amendment.--Subsections (d), (e), (f), and 
     (g) of section 511 of the Antiterrorism and Effective Death 
     Penalty Act of 1996 (42 U.S.C. 262 note) are repealed.
       (3) Date certain for promulgation of certain regulations; 
     effective date regarding criminal and civil penalties.--With 
     respect to section 351A of the Public Health Service Act (as 
     added by paragraph (1) of this subsection):
       (A) Not later than 30 days after the date of the enactment 
     of this Act, the Secretary of Health and Human Services shall 
     promulgate an interim final rule requiring all persons in 
     possession of biological agents or toxins listed pursuant to 
     subsection (a)(1) of such section (unless exempt under 
     subsection (e) of such section) to provide notice to the 
     Secretary of such possession, and to include in the notice 
     such additional information as the Secretary may require for 
     compliance with subsection (d) of such section or any other 
     provision of such section, by not later than 30 days after 
     the date on which such rule is promulgated. Such interim 
     final rule takes effect on the date on which the rule is 
     promulgated, except as follows:
       (i) For purposes of section 175b(c) of title 18, United 
     States Code (relating to criminal penalties), as added by 
     subsection (a)(1)(E) of this section, the rule takes effect 
     60 days after the date on which the rule is promulgated.
       (ii) For purposes of subsection (i) of such section 351A 
     (relating to civil penalties), the rule takes effect 60 days 
     after the date on which the rule is promulgated.
       (B) Not later than 120 days after the date of enactment of 
     this Act, such Secretary shall promulgate an interim final 
     rule for carrying out subsections (b) and (c) of such section 
     351A. Such interim final rule takes effect 60 days after the 
     date on which the rule is promulgated.
       (4) Effective date regarding disclosure of information.--
     Subsection (h) of section 351A of the Public Health Service 
     Act, as added by paragraph (1) of this subsection, is deemed 
     to have taken effect on the effective date of the 
     Antiterrorism and Effective Death Penalty Act of 1996.
       (b) Criminal Penalties Regarding Select Agents.--
       (1) In general.--Section 175b of title 18, United States 
     Code, as added by section 817 of Public Law 107-56, is 
     amended--
       (A) by striking ``(a)'' and inserting ``(a)(1)'';
       (B) by transferring subsection (c) from the current 
     placement of the subsection and inserting the subsection 
     before subsection (b);
       (C) by striking ``(c)'' and inserting ``(2);
       (D) by redesignating subsection (b) as subsection (d); and
       (E) by inserting before subsection (d) (as so redesignated) 
     the following subsections:
       ``(b) Transfer to Unregistered Person.--Whoever knowingly 
     transfers a select agent to a person without first verifying 
     with the Secretary of Health and Human Services that the 
     person has obtained a registration required by regulations 
     under subsection (b) or (c) of section 351A of the Public 
     Health Service Act shall be fined under this title, or 
     imprisoned for not more than 5 years, or both.
       ``(c) Unregistered for Possession.--Whoever knowingly 
     possesses a biological agent or toxin where such agent or 
     toxin is a select agent for which such person has not 
     obtained a registration required by regulations under section 
     351A(c) of the Public Health Service Act shall be fined under 
     this title, or imprisoned for not more than 5 years, or 
     both.''.
       (2) Conforming amendments.--Chapter 10 of title 18, United 
     States Code, is amended--
       (A) in section 175b (as added by section 817 of Public Law 
     107-56 and amended by paragraph (1) of this subsection)--
       (i) in subsection (d)(1), by striking ``The term'' and all 
     that follows through ``does not include'' and inserting the 
     following: ``The term `select agent' means a biological agent 
     or toxin to which subsection (a) applies. Such term 
     (including for purposes of subsection (a)) does not 
     include''; and
       (ii) in the heading for the section, by striking 
     ``Possession by restricted persons'' and inserting ``Select 
     agents''; and
       (B) in the chapter analysis, in the item relating to 
     section 175b, by striking ``Possession by restricted 
     persons.'' and inserting ``Select agents.''.
       (3) Technical corrections.--Chapter 10 of title 18, United 
     States Code, as amended by section 817 of Public Law 107-56 
     and paragraphs (1) and (2) of this subsection, is amended--
       (A) in section 175--
       (i) in subsection (a), in the second sentence, by striking 
     ``this section'' and inserting ``this subsection''; and
       (ii) in subsection (c), by striking ``protective'' and all 
     that follows and inserting ``protective, bona fide research, 
     or other peaceful purposes.'';
       (B) in section 175b--
       (i) in subsection (a)(1), by striking ``described in 
     subsection (b)'' and all that follows and inserting the 
     following: ``shall ship or transport in or affecting 
     interstate or foreign commerce, or possess in or affecting 
     interstate or foreign commerce, any biological agent or 
     toxin, or receive any biological agent or toxin that has been 
     shipped or

[[Page H9205]]

     transported in interstate or foreign commerce, if the 
     biological agent or toxin is listed as a select agent in 
     Appendix A of part 72 of title 42, Code of Federal 
     Regulations, pursuant to section 351A of the Public Health 
     Service Act, and is not exempted under subsection (h) of 
     section 72.6, or Appendix A of part 72, of title 42, Code of 
     Federal Regulations.''; and
       (ii) in subsection (d)(3), by striking ``section 
     1010(a)(3)'' and inserting ``section 101(a)(3)'';
       (C) in section 176(a)(1)(A), by striking ``exists by reason 
     of'' and inserting ``pertains to''; and
       (D) in section 178--
       (i) in paragraph (1), by striking ``means any micro-
     organism'' and all that follows through ``product, capable 
     of'' and inserting the following: ``means any microorganism 
     (including, but not limited to, bacteria, viruses, fungi, 
     rickettsiae or protozoa), or infectious substance, or any 
     naturally occurring, bioengineered or synthesized component 
     of any such microorganism or infectious substance, capable 
     of'';
       (ii) in paragraph (2), by striking ``means the toxic'' and 
     all that follows through ``including--'' and inserting the 
     following: ``means the toxic material or product of plants, 
     animals, microorganisms (including, but not limited to, 
     bacteria, viruses, fungi, rickettsiae or protozoa), or 
     infectious substances, or a recombinant or synthesized 
     molecule, whatever their origin and method of production, and 
     includes--''; and
       (iii) in paragraph (4), by striking ``recombinant 
     molecule,'' and all that follows through ``biotechnology,'' 
     and inserting ``recombinant or synthesized molecule,''.
       (4) Additional technical correction.--Section 2332a of 
     title 18, United States Code, is amended--
       (A) in subsection (a), in the matter preceding paragraph 
     (1), by striking ``section 229F)'' and all that follows 
     through ``section 178)--'' and inserting ``section 229F)--''; 
     and
       (B) in subsection (c)(2)(C), by striking ``a disease 
     organism'' and inserting ``a biological agent, toxin, or 
     vector (as those terms are defined in section 178 of this 
     title)''.
       (c) Security Upgrades at the Department of Health and Human 
     Services.--For the purpose of enabling the Secretary of 
     Health and Human Services to secure existing facilities of 
     the Department of Health and Human Services where biological 
     agents or toxins listed under section 351A(a)(1) of the 
     Public Health Service Act are housed or researched, or where 
     vaccines are housed or researched, there are authorized to be 
     appropriated such sums as may be necessary for fiscal year 
     2002 and each subsequent fiscal year.
       (d) Report to Congress.--Not later than 1 year after the 
     date of the enactment of this Act, the Secretary of Health 
     and Human Services, after consultation with other appropriate 
     Federal agencies, shall submit to the Congress a report 
     that--
       (1) describes the extent to which there has been compliance 
     by governmental and private entities with applicable 
     regulations under section 351A of the Public Health Service 
     Act (as added by subsection (a) of this section), including 
     the extent of compliance before the date of the enactment of 
     this Act, and including the extent of compliance with 
     regulations promulgated after such date of enactment;
       (2) describes the actions to date and future plans of the 
     Secretary for updating the list of biological agents and 
     toxins under such section 351A;
       (3) describes the actions to date and future plans of the 
     Secretary for determining compliance with regulations under 
     such section 351A and for taking appropriate enforcement 
     actions; and
       (4) provides any recommendations of the Secretary for 
     administrative or legislative initiatives regarding such 
     section 351A.

      TITLE III-AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT

                 Subtitle A--Protection of Food Supply

     SEC. 301. PROTECTION AGAINST INTENTIONAL ADULTERATION OF 
                   FOOD.

       (a) Increasing Inspections for Detection of Intentional 
     Adulteration of Food.--Section 801 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381) is amended by adding at the 
     end the following subsection:
       ``(h)(1) The Secretary shall give high priority to 
     increasing the number of inspections under this section for 
     the purpose of enabling the Secretary to inspect food offered 
     for import at ports of entry into the United States, with the 
     greatest priority given to inspections to detect the 
     intentional adulteration of food.''.
       (b) Improvements to Information Management Systems.--
     Section 801(h) of the Federal Food, Drug, and Cosmetic Act, 
     as added by subsection (a) of this section, is amended by 
     adding at the end the following paragraphs:
       ``(2) The Secretary shall give high priority to making 
     necessary improvements to the information management systems 
     of the Food and Drug Administration that contain information 
     related to foods imported or offered for import into the 
     United States for purposes of improving the ability of the 
     Secretary to allocate resources, detect the intentional 
     adulteration of food, and facilitate the importation of food 
     that is in compliance with this Act.
       ``(3) The Secretary shall submit to the Committee on Energy 
     and Commerce of the House of Representatives, and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate, periodic reports describing the activities of the 
     Secretary under paragraphs (1) and (2).''.
       (c) Testing for Rapid Detection of Intentional Adulteration 
     of Food.--Section 801 of the Federal Food, Drug, and Cosmetic 
     Act, as amended by subsection (a) of this section, is amended 
     by adding at the end the following:
       ``(i)(1) For use in inspections of food under this section, 
     the Secretary shall provide for research on the development 
     of tests and sampling methodologies--
       ``(A) whose purpose is to test food in order to rapidly 
     detect the adulteration of the food, with the greatest 
     priority given to detect the intentional adulteration of 
     food; and
       ``(B) whose results offer significant improvements over the 
     available technology in terms of accuracy, timing, or costs.
       ``(2) In providing for research under paragraph (1), the 
     Secretary shall give priority to conducting research on the 
     development of tests that are suitable for inspections of 
     food at ports of entry into the United States.
       ``(3) In providing for research under paragraph (1), the 
     Secretary shall as appropriate coordinate with the Director 
     of the Centers for Disease Control and Prevention, the 
     Director of the National Institutes of Health, the 
     Administrator of the Environmental Protection Agency, and the 
     Secretary of Agriculture.
       ``(4) The Secretary shall annually submit to the Committee 
     on Energy and Commerce of the House of Representatives, and 
     the Committee on Health, Education, Labor, and Pensions of 
     the Senate, a report describing the progress made in research 
     under paragraph (1), including progress regarding paragraph 
     (2).''.
       (d) Assessment of Threat of Intentional Adulteration of 
     Food.--The Secretary of Health and Human Services, acting 
     through the Commissioner of Food and Drugs, shall ensure 
     that, not later than six months after the date of the 
     enactment of this Act--
       (1) the assessment that (as of such date of enactment) is 
     being conducted on the threat of the intentional adulteration 
     of food is completed; and
       (2) a report describing the findings of the assessment is 
     submitted to the Committee on Energy and Commerce of the 
     House of Representatives and to the Committee on Health, 
     Education, Labor, and Pensions of the Senate.
       (e) Authorization of Appropriations.--For the purpose of 
     carrying out this section and the amendments made by this 
     section, there are authorized to be appropriated $100,000,000 
     for fiscal year 2002, and such sums as may be necessary for 
     each of the fiscal years 2003 through 2006, in addition to 
     other authorizations of appropriations that are available for 
     such purpose.

     SEC. 302. ADMINISTRATIVE DETENTION.

       (a) Expanded Authority.--Section 304 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding 
     at the end the following subsection:
       ``(h) Administrative Detention of Foods.--
       ``(1) Detention authority.--
       ``(A) In general.--An officer or qualified employee of the 
     Food and Drug Administration may order the detention, in 
     accordance with this subsection, of any article of food that 
     is found during an inspection, examination, or investigation 
     under this Act conducted by such officer or qualified 
     employee, if the officer or qualified employee has credible 
     evidence or information indicating that such article presents 
     a threat of serious adverse health consequences or death to 
     humans or animals.
       ``(B) Secretary's approval.--An article of food may be 
     ordered detained under subparagraph (A) only if the Secretary 
     or an official designated by the Secretary approves the 
     order. An official may not be so designated unless the 
     official is the director of the district under this Act in 
     which the article involved is located, or is an official 
     senior to such director.
       ``(2) Period of detention.--An article of food may be 
     detained under paragraph (1) for a reasonable period, not to 
     exceed 20 days, unless a greater period, not to exceed 30 
     days, is necessary, to enable the Secretary to institute an 
     action under subsection (a) or section 302. The Secretary 
     shall by regulation provide for procedures for instituting 
     such action on an expedited basis with respect to perishable 
     foods.
       ``(3) Security of detained article.--An order under 
     paragraph (1) with respect to an article of food may require 
     that such article be labeled or marked as detained, and may 
     require that the article be removed to a secure facility. An 
     article subject to such an order shall not be transferred by 
     any person from the place at which the article is ordered 
     detained, or from the place to which the article is so 
     removed, as the case may be, until released by the Secretary 
     or until the expiration of the detention period applicable 
     under such order, whichever occurs first.
       ``(4) Appeal of detention order.--With respect to an 
     article of food ordered detained under paragraph (1), any 
     person who would be entitled to be a claimant for such 
     article if the article were seized under subsection (a) may 
     appeal the order to the Secretary. Within 72 hours after such 
     an appeal is filed, the Secretary, after providing 
     opportunity for an informal hearing, shall confirm or 
     terminate the order involved, and such confirmation by the 
     Secretary shall be considered a final agency action for 
     purposes of section 702 of

[[Page H9206]]

     title 5, United States Code. If during such 72-hour period 
     the Secretary fails to provide such an opportunity, or to 
     confirm or terminate such order, the order is deemed to be 
     terminated.''.
       (b) Prohibited Act.--Section 301 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 331) is amended by adding at the 
     end the following:
       ``(bb) The transfer of an article of food in violation of 
     an order under section 304(h), or the removal or alteration 
     of any mark or label required by the order to identify the 
     article as detained.''.
       (c) Temporary Holds at Ports of Entry.--Section 801 of the 
     Federal Food, Drug, and Cosmetic Act, as amended by section 
     301(c) of this Act, is amended by adding at the end the 
     following:
       ``(j)(1) If an officer or qualified employee of the Food 
     and Drug Administration has credible evidence or information 
     indicating that an article of food presents a threat of 
     serious adverse health consequences or death to humans or 
     animals, and such officer or qualified employee is unable to 
     inspect, examine, or investigate such article upon the 
     article being offered for import at a port of entry into the 
     United States, the officer or qualified employee shall 
     request the Secretary of Treasury to hold the food at the 
     port of entry for a reasonable period of time, not to exceed 
     24 hours, for the purpose of enabling the Secretary to 
     inspect, examine, or investigate the article as appropriate.
       ``(2) The Secretary shall request the Secretary of Treasury 
     to remove an article held pursuant to paragraph (1) to a 
     secure facility, as appropriate. During the period of time 
     that such article is so held, the article shall not be 
     transferred by any person from the port of entry into the 
     United States for the article, or from the secure facility to 
     which the article has been removed, as the case may be.
       ``(3) An officer or qualified employee of the Food and Drug 
     Administration may make a request under paragraph (1) only if 
     the Secretary or an official designated by the Secretary 
     approves the request. An official may not be so designated 
     unless the official is the director of the district under 
     this Act in which the article involved is located, or is an 
     official senior to such director.
       ``(4) With respect to an article of food for which a 
     request under paragraph (1) is made, the Secretary, promptly 
     after the request is made, shall notify the State in which 
     the port of entry involved is located that the request has 
     been made, and as applicable, that such article is being held 
     under this subsection.''.

     SEC. 303. PERMISSIVE DEBARMENT REGARDING FOOD IMPORTATION.

       (a) In General.--Section 306(b) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 335a(b)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (A), by striking ``or'' after the comma 
     at the end;
       (B) in subparagraph (B), by striking the period at the end 
     and inserting ``, or''; and
       (C) by adding at the end the following subparagraph:
       ``(C) a person from importing an article of food or 
     offering such an article for import into the United 
     States.'';
       (2) in paragraph (2), in the matter preceding subparagraph 
     (A), by inserting ``subparagraph (A) or (B) of'' before 
     ``paragraph (1)'';
       (3) by redesignating paragraph (3) as paragraph (4); and
       (4) by inserting after paragraph (2) the following 
     paragraph:
       ``(3) Persons subject to permissive debarment; food 
     importation.--A person is subject to debarment under 
     paragraph (1)(C) if--
       ``(A) the person has been convicted of a felony for conduct 
     relating to the importation into the United States of any 
     article of food; or
       ``(B)(i) the person has repeatedly imported or offered for 
     import adulterated articles of food; and
       ``(ii) the person knew, or should have known, that such 
     articles were adulterated.''.
       (b) Conforming Amendments.--Section 306 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is amended--
       (1) in subsection (a), in the heading for the subsection, 
     by striking ``Mandatory Debarment.--'' and inserting 
     ``Mandatory Debarment; Certain Drug Applications.--'';
       (2) in subsection (b)--
       (A) in the heading for the subsection, by striking 
     ``Permissive Debarment.--'' and inserting ``Permissive 
     Debarment; Certain Drug Applications; Food Imports.--''; and
       (B) in paragraph (2), in the heading for the paragraph, by 
     striking ``permissive debarment.--'' and inserting 
     ``permissive debarment; certain drug applications.--'';
       (3) in subsection (c)(2)(A)(iii), by striking ``subsection 
     (b)(2)'' and inserting ``paragraph (2) or (3) of subsection 
     (b)'';
       (4) in subsection (d)(3)--
       (A) in subparagraph (A)(i), by striking ``or (b)(2)(A)'' 
     and inserting `` or paragraph (2)(A) or (3) of subsection 
     (b)'';
       (B) in subparagraph (A)(ii)(II), by inserting ``in 
     applicable cases,'' before ``sufficient audits''; and
       (C) in subparagraph (B), in each of clauses (i) and (ii), 
     by inserting ``or subsection (b)(3)'' after ``subsection 
     (b)(2)(B).
       (c) Effective Dates.--Section 306(l)(2) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) is 
     amended--
       (1) in the first sentence--
       (A) by striking ``and'' after ``subsection (b)(2)''; and
       (B) by inserting ``, and subsection (b)(3)'' after 
     ``subsection (b)(2)(B)''; and
       (2) in the second sentence, by inserting ``, subsection 
     (b)(3),'' after ``subsection (b)(2)(B)''.
       (d) Prohibited Act.--Section 301 of the Federal Food, Drug, 
     and Cosmetic Act, as amended by section 302(b) of this Act, 
     is amended by adding at the end the following:
       ``(cc) The importing or offering for import into the United 
     States of an article of food by, with the assistance of, or 
     at the direction of, a person debarred under section 
     306(b)(1)(C).''.

     SEC. 304. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.

       (a) In General.--Chapter IV of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at 
     the end the following section:

     ``SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.

       ``(a) Records Inspection.--If the Secretary has credible 
     evidence or information indicating that an article of food 
     presents a threat of serious adverse health consequences or 
     death to humans or animals, each person (excluding farms and 
     restaurants) who manufactures, processes, packs, distributes, 
     receives, holds, or imports such article shall, at the 
     request of an officer or employee duly designated by the 
     Secretary, permit such officer or employee, upon presentation 
     of appropriate credentials and a written notice to such 
     person, at reasonable times and within reasonable limits and 
     in a reasonable manner, to have access to and copy all 
     records relating to such article that are needed to assist 
     the Secretary in investigating such credible evidence or 
     information. The requirement under the preceding sentence 
     applies to all records relating to the manufacture, 
     processing, packing, distribution, receipt, holding, or 
     importation of such article maintained by or on behalf of 
     such person in any format (including paper and electronic 
     formats) and at any location.
       ``(b) Regulations Concerning Recordkeeping.--The Secretary, 
     in consultation and coordination, as appropriate, with other 
     Federal departments and agencies with responsibilities for 
     regulating food safety, may by regulation establish 
     requirements regarding the maintenance of records by persons 
     (excluding farms and restaurants) who manufacture, process, 
     pack, transport, distribute, receive, hold, or import food, 
     as may be necessary to trace the source and chain of 
     distribution of food and its packaging in order to address 
     credible threats of serious adverse health consequences or 
     death to humans or animals. The Secretary shall take into 
     account the size of a business in promulgating regulations 
     under this section.
       ``(c) Protection of Sensitive Information.--The Secretary 
     shall take appropriate measures to ensure that there are in 
     effect effective procedures to prevent the unauthorized 
     disclosure of any trade secret or confidential information 
     that is obtained by the Secretary pursuant to this section.
       ``(d) Limitations.--This section shall not be construed--
       ``(1) to limit the authority of the Secretary to inspect 
     records or to require maintenance of records under any other 
     provision of this Act;
       ``(2) to authorize the Secretary to impose any requirements 
     with respect to a food to the extent that it is within the 
     exclusive jurisdiction of the Secretary of Agriculture 
     pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et 
     seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et 
     seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et 
     seq);
       ``(3) to have any legal effect on section 552 of title 5, 
     United States Code, or section 1905 of title 18, United 
     States Code; or
       ``(4) to extend to recipes for food, financial data, 
     pricing data, personnel data, research data, or sales data 
     (other than shipment data regarding sales).''.
       (b) Factory Inspection.--Section 704(a) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended--
       (1) in paragraph (1), by inserting after the first sentence 
     the following new sentence: ``In the case of any person 
     (excluding farms and restaurants) who manufactures, 
     processes, packs, transports, distributes, holds, or imports 
     foods, the inspection shall extend to all records and other 
     information described in section 414 when the Secretary has 
     credible evidence or information indicating that an article 
     of food presents a threat of serious adverse health 
     consequences or death to humans or animals, subject to the 
     limitations established in section 414(d).''; and
       (2) in paragraph (2), in the matter preceding subparagraph 
     (A), by striking ``second sentence'' and inserting ``third 
     sentence''.
       (c) Prohibited Act.--Section 301(e) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331(e)) is amended--
       (1) by striking ``by section 412, 504, or 703'' and 
     inserting ``by section 412, 414, 504, 703, or 704(a); and
       (2) by striking ``under section 412'' and inserting ``under 
     section 412, 414(b)''.

     SEC. 305. REGISTRATION.

       (a) In General.--Chapter IV of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 341 et seq.), as amended by section 
     304 of this Act, is amended by adding at the end the 
     following:

     ``SEC. 415. REGISTRATION.

       ``(a) Registration.--

[[Page H9207]]

       ``(1) In general.--Any facility (excluding farms) engaged 
     in manufacturing, processing, packing, or holding food for 
     consumption in the United States shall be registered with the 
     Secretary. To be registered--
       ``(A) for a domestic facility, the owner, operator, or 
     agent in charge of the facility shall submit a registration 
     to the Secretary; and
       ``(B) for a foreign facility, the owner, operator, or agent 
     in charge of the facility shall submit a registration to the 
     Secretary and shall include with the registration the name of 
     the United States agent for the facility.
       ``(2) Registration.--An entity (referred to in this section 
     as the `registrant') shall submit a registration under 
     paragraph (1) to the Secretary containing information 
     necessary to notify the Secretary of the identity and address 
     of each facility at which, and all trade names under which, 
     the registrant conducts business and, when determined 
     necessary by the Secretary through guidance, the general food 
     category (as identified under section 170.3 of title 21, Code 
     of Federal Regulations, or successor regulations) of any food 
     manufactured, processed, packed, or held at such facility. 
     The registrant shall notify the Secretary in a timely manner 
     of changes to such information.
       ``(3) Procedure.--Upon receipt of a completed registration 
     described in paragraph (1), the Secretary shall notify the 
     registrant of the receipt of such registration and assign a 
     registration number to each registered facility.
       ``(4) List.--The Secretary shall compile and maintain an 
     up-to-date list of facilities that are registered under this 
     section. Such list and other information required to be 
     submitted under this subsection shall not be subject to the 
     disclosure requirements of section 552 of title 5, United 
     States Code.
       ``(b) Exemption.--The Secretary shall by regulation exempt 
     types of retail establishments from the requirements of 
     subsection (a) only if the Secretary determines that the 
     registration of such facilities is not needed for effective 
     enforcement of this chapter and any regulations issued under 
     this chapter.
       ``(c) Facility.--For purposes of this section, the term 
     `facility' includes any factory, warehouse, or establishment 
     (including a factory, warehouse, or establishment of an 
     importer), that manufactures, processes, packs, or holds 
     food. Such term does not include restaurants or other 
     establishments in which food is served solely for immediate 
     human consumption.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed to authorize the Secretary to require an 
     application, review, or licensing process.''.
       (b) Prohibited Acts.--
       (1) In general.--Section 301 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 331), as amended by section 303(d) of 
     this Act, is amended by adding at the end the following:
       ``(dd) The failure to register in accordance with section 
     415.''.
       (2) Misbranded food.--Section 403 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding 
     at the end the following:
       ``(t) If it is manufactured, processed, packed, or held in 
     a facility that is not registered in accordance with section 
     415.''.
       (c) Effective Date.--The amendment made by subsection (b) 
     shall take effect 180 days after the date of the enactment of 
     this Act.
       (d) Notice.--Not later than 60 days after the date of the 
     enactment of this Act, the Secretary of Health and Human 
     Services, after consultation with appropriate State and local 
     officials, shall take sufficient measures to notify entities 
     that manufacture, process, pack, or hold food for consumption 
     in the United States of the requirement pursuant to this 
     section that facilities be registered with the Secretary. The 
     Secretary shall develop guidance, as needed, to identify 
     facilities required to register under this section.
       (e) Electronic Filing.--For the purpose of reducing 
     paperwork and reporting burdens, the Secretary of Health and 
     Human Services may provide for, and encourage the use of, 
     electronic methods of submitting to the Secretary 
     registrations required pursuant to this section. In providing 
     for the electronic submission of such registrations, the 
     Secretary shall ensure adequate authentication protocols are 
     used to enable identification of the registrant and 
     validation of the data as appropriate.
       (f) Savings Clause.--This section may not be construed as 
     authorizing the Secretary of Health and Human Services to 
     impose any requirements with respect to a food to the extent 
     that it is within the exclusive jurisdiction of the Secretary 
     of Agriculture pursuant to the Federal Meat Inspection Act 
     (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act 
     (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act 
     (21 U.S.C. 1031 et seq).

     SEC. 306. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

       (a) In General.--Section 801 of the Federal Food, Drug, and 
     Cosmetic Act, as amended by section 302(c) of this Act, is 
     amended by adding at the end the following subsection:
       ``(k)(1) In the case of an article of food that is being 
     imported or offered for import into the United States, the 
     Secretary, after consultation with the Secretary of the 
     Treasury, shall by regulation require, for the purpose of 
     enabling such article to be inspected at ports of entry into 
     the United States, the submission to the Secretary of a 
     notice providing the identity of each of the following: The 
     article; the manufacturer and shipper of the article, and if 
     known within the specified period of time that notice is 
     required to be provided, the grower of the article; the 
     country from which the article originates; the country from 
     which the article is shipped; and the anticipated port of 
     entry for the article. An article of food imported or offered 
     for import without submission of such notice in accordance 
     with regulations under this paragraph shall be refused 
     admission into the United States. Nothing in this section may 
     be construed as a limitation on the port of entry for an 
     article of food.
       ``(2)(A) Regulations under paragraph (1) shall require that 
     a notice under such paragraph be provided by a specified 
     period of time, not fewer than 24 hours, in advance of the 
     time of the importation of the article of food involved or 
     the offering of the food for import, except that the advance 
     period so required may not exceed 72 hours.
       ``(B)(i) If an article of food is being imported or offered 
     for import into the United States and a notice under 
     paragraph (1) is not provided in advance in accordance with 
     subparagraph (A), such article shall be held at the port of 
     entry for the article, and may not be delivered to the 
     importer, owner, or consignee of the article, until such 
     notice is submitted to the Secretary, and the Secretary 
     examines the notice and determines that the notice is in 
     accordance with regulations under paragraph (1). The 
     preceding sentence may not be construed as authorizing such 
     delivery pursuant to the execution of a bond, pending such a 
     determination by the Secretary.
       ``(ii) In carrying out clause (i) with respect to an 
     article of food, the Secretary shall determine whether there 
     is in the possession of the Secretary any credible evidence 
     or information indicating that such article presents a threat 
     of serious adverse health consequences or death to humans or 
     animals.
       ``(3)(A) This subsection may not be construed as limiting 
     the authority of the Secretary to obtain information under 
     any other provision of this Act.
       ``(B) This subsection may not be construed as authorizing 
     the Secretary to impose any requirements with respect to a 
     food to the extent that it is within the exclusive 
     jurisdiction of the Secretary of Agriculture pursuant to the 
     Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the 
     Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or 
     the Egg Products Inspection Act (21 U.S.C. 1031 et seq).''.
       (b) Prohibited Act.--Section 301 of the Federal Food, Drug, 
     and Cosmetic Act, as amended by section 305(b)(1) of this 
     Act, is amended by adding at the end the following:
       ``(ee) The importing or offering for import into the United 
     States of an article of food in violation of regulations 
     under section 801(k).''.

     SEC. 307. AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO 
                   UNITED STATES.

       (a) In General.--Section 801 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 381(a)), as amended by section 306(a) 
     of this Act, is amended by adding at the end the following:
       ``(l)(1) If a food has been refused admission under 
     subsection (a), other than such a food that is required to be 
     destroyed, and the Secretary determines that the food 
     presents a threat of serious adverse health consequences or 
     death to humans or animals, the Secretary may require the 
     owner or consignee of the food to affix to the container of 
     the food a label that clearly and conspicuously bears the 
     statement: `UNITED STATES: REFUSED ENTRY'.
       ``(2) All expenses in connection with affixing a label 
     under paragraph (1) shall be paid by the owner or consignee 
     of the food involved, and in default of such payment, shall 
     constitute a lien against future importations made by such 
     owner or consignee.
       ``(3) A requirement under paragraph (1) remains in effect 
     until the Secretary determines that the food involved has 
     been brought into compliance with this Act.''.
       (b) Misbranded Foods.--Section 403 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 343), as amended by section 
     305(b)(2) of this Act, is amended by adding at the end the 
     following:
       ``(u) If it fails to bear a label required by the Secretary 
     under section 801(l)(1) (relating to food refused admission 
     into the United States).''.
       (c) Rule of Construction.--With respect to articles of food 
     that are imported or offered for import into the United 
     States, nothing in this section shall be construed to limit 
     the authority of the Secretary of Health and Human Services 
     or the Secretary of the Treasury to require the marking of 
     refused articles of food under any other provision of law.

     SEC. 308. PROHIBITION AGAINST PORT SHOPPING FOR IMPORTATION.

       Section 402 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 342) is amended by adding at the end the following:
       ``(h) If it is an article of food imported or offered for 
     import into the United States and such article has previously 
     been refused admission under section 801(a), unless the 
     person reoffering the article affirmatively establishes, at 
     the expense of the owner or consignee of the article, that 
     the article is not adulterated, as determined by the 
     Secretary.''.

     SEC. 309. NOTICES TO STATES REGARDING IMPORTED FOOD.

       Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 391 et seq.) is amended by adding at the end the 
     following new section:

[[Page H9208]]

     ``SEC. 908. NOTICES TO STATES REGARDING IMPORTED FOOD.

       ``(a) In General.--If the Secretary has credible evidence 
     or information indicating that a shipment of imported food or 
     portion thereof presents a threat of serious adverse health 
     consequences or death to humans or animals, the Secretary 
     shall provide notice regarding such threat to the States in 
     which the food is held or will be held, and to the States in 
     which the manufacturer, packer, or distributor of the food is 
     located, to the extent that the Secretary has knowledge of 
     which States are so involved. In providing the notice to a 
     State, the Secretary shall request the State to take such 
     action as the State considers appropriate, if any, to protect 
     the public health regarding the food involved.
       ``(b) Rule of Construction.--Subsection (a) may not be 
     construed as limiting the authority of the Secretary with 
     respect to adulterated food under any other provision of this 
     Act.''.

     SEC. 310. GRANTS TO STATES FOR INSPECTIONS; RESPONSE TO 
                   NOTICE REGARDING ADULTERATED IMPORTED FOOD.

       Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 391 et seq.), as amended by section 309 of this Act, 
     is amended by adding at the end the following new section:

     ``SEC. 909. GRANTS TO STATES REGARDING FOOD INSPECTIONS.

       ``(a) In General.--The Secretary may make grants to States 
     and Territories for the purpose of conducting with respect to 
     food examinations, inspections, investigations, and related 
     activities under section 702 through individuals who, under 
     subsection (a) of such section, are duly commissioned by the 
     Secretary as officers of the Department.
       ``(b) Notices Regarding Adulterated Imported Food.--The 
     Secretary may make grants to the States for the purpose of 
     assisting the States with the costs of taking appropriate 
     action to protect the public health in response to notices 
     under section 908, including planning and otherwise preparing 
     to take such action.
       ``(c) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 2002 through 2006.''.

                 Subtitle B--Protection of Drug Supply

     SEC. 311. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS; 
                   SHIPPING INFORMATION; DRUG AND DEVICE LISTING.

       (a) Annual Registration; Listing.--
       (1) In general.--Section 510 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360) is amended--
       (A) in subsection (i)(1)--
       (i) by striking ``Any establishment'' and inserting ``On or 
     before December 31 of each year, any establishment'';
       (ii) by striking ``establishment and the name'' and 
     inserting ``establishment, the name''; and
       (iii) by inserting before the period the following: ``, the 
     name of each importer of such drug or device in the United 
     States that is known to the establishment, and the name of 
     each carrier used by the establishment in transporting such 
     drug or device to the United States for purposes of 
     importation''; and
       (B) in subsection (j)(1), in the first sentence, by 
     striking ``or (d)'' and inserting ``(d), or (i)''.
       (2) Misbranding.--Section 502(o) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352(o)) is amended by striking 
     ``in any State''.
       (b) Importation; Statement Regarding Registration of 
     Manufacturer.--
       (1) In general.--Section 801 of the Federal Food, Drug, and 
     Cosmetic Act, as amended by section 307(a) of this Act, is 
     amended by adding at the end the following subsection:
       ``(m) A drug or device that is imported or offered for 
     import into the United States may be refused admission if the 
     importer of the drug or device does not, at the time of 
     offering the drug or device for import, submit to the 
     Secretary a statement that identifies the registration under 
     section 510(i) of each establishment that with respect to 
     such drug or device is required under such section to 
     register with the Secretary.''.
       (2) Prohibited act.--Section 301 of the Federal Food, Drug, 
     and Cosmetic Act, as amended by section 306(b) of this Act, 
     is amended by adding at the end the following:
       ``(ff) The importing or offering for import into the United 
     States of a drug or device with respect to which there is a 
     failure to comply with an order of the Secretary to submit to 
     the Secretary a statement under section 801(m).''.
       (c) Effective Date.--The amendments made by this section 
     take effect upon the expiration of the 180-day period 
     beginning on the date of the enactment of this Act.

     SEC. 312. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING 
                   IMPORT COMPONENTS INTENDED FOR USE IN EXPORT 
                   PRODUCTS.

       (a) In General.--Section 801(d)(3) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to 
     read as follows:
       ``(3)(A) Subject to subparagraph (B), no component of a 
     drug, no component part or accessory of a device, or other 
     article of device requiring further processing, which is 
     ready or suitable for use for health-related purposes, and no 
     article of a food additive, color additive, or dietary 
     supplement, including a product in bulk form, shall be 
     excluded from importation into the United States under 
     subsection (a) if each of the following conditions is met:
       ``(i) The importer of such article of a drug or device or 
     importer of such article of a food additive, color additive, 
     or dietary supplement submits to the Secretary, at the time 
     of initial importation, a statement in accordance with the 
     following:
       ``(I) Such statement provides that such article is intended 
     to be further processed by the initial owner or consignee, or 
     incorporated by the initial owner or consignee, into a drug, 
     biological product, device, food, food additive, color 
     additive, or dietary supplement that will be exported by the 
     initial owner or consignee from the United States in 
     accordance with subsection (e) or section 802, or with 
     section 351(h) of the Public Health Service Act.
       ``(II) The statement identifies the manufacturer of such 
     article and each processor, packer, distributor, carrier, or 
     other entity that had possession of the article in the chain 
     of possession of the article from the manufacturer to such 
     importer of the article.
       ``(ii) If such article is known to be, or to contain or 
     bear, any chemical substance or biological substance, the 
     statement under clause (i) is accompanied by such 
     certificates of analysis as are necessary to identify each 
     such substance.
       ``(iii) At the time of initial importation and before the 
     delivery of such article to the importer or the initial owner 
     or consignee, such owner or consignee executes a good and 
     sufficient bond providing for the payment of such liquidated 
     damages in the event of default as may be required pursuant 
     to regulations of the Secretary of the Treasury.
       ``(iv) Such article is used and exported by the initial 
     owner or consignee in accordance with the intent described 
     under clause (i)(I), except for any portions of the article 
     that are destroyed.
       ``(v) The initial owner or consignee maintains records on 
     the use or destruction of such article or portions thereof, 
     as the case may be, and submits to the Secretary any such 
     records requested by the Secretary.
       ``(vi) Upon request of the Secretary, the initial owner or 
     consignee submits a report that provides an accounting of the 
     exportation or destruction of such article or portions 
     thereof, and the manner in which such owner or consignee 
     complied with the requirements of this subparagraph.
       ``(B) Subparagraph (A) does not apply to the import or 
     offering for import into the United States of an article if 
     the Secretary determines that there is credible evidence or 
     information indicating that such article presents a threat of 
     serious adverse health consequences or death to humans or 
     animals.
       ``(C) This section may not be construed as affecting the 
     responsibility of the Secretary to ensure that articles 
     imported into the United States under authority of 
     subparagraph (A) meet each of the conditions established in 
     such subparagraph for importation.''.
       (b) Prohibited Act.--Section 301(w) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331(w)) is amended to read 
     as follows:
       ``(w) The making of a knowingly false statement in any 
     statement, certificate of analysis, record, or report 
     required or requested under section 801(d)(3); the failure to 
     submit a certificate of analysis as required under such 
     section; the failure to maintain records or to submit records 
     or reports as required by such section; the release into 
     interstate commerce of any article or portion thereof 
     imported into the United States under such section or any 
     finished product made from such article or portion, except 
     for export in accordance with section 801(e) or 802, or with 
     section 351(h) of the Public Health Service Act; or the 
     failure to so export or to destroy such an article or 
     portions thereof, or such a finished product.''.
       (c) Effective Date.--The amendments made by this section 
     take effect upon the expiration of the 90-day period 
     beginning on the date of the enactment of this Act.

              TITLE IV-DRINKING WATER SECURITY AND SAFETY

     SEC. 401. AMENDMENT OF THE SAFE DRINKING WATER ACT.

       The Safe Drinking Water Act (title XIV of the Public Health 
     Service Act) is amended as follows:
       (1) By inserting the following new sections after section 
     1432:

     ``SEC. 1433. TERRORIST AND OTHER INTENTIONAL ACTS.

       ``(a) Vulnerability Assessments.--(1) Each community water 
     system serving a population of greater than 3,300 persons 
     shall conduct an assessment of the vulnerability of its 
     system to a terrorist attack or other intentional acts 
     intended to substantially disrupt the ability of the system 
     to provide a safe and reliable supply of drinking water. The 
     vulnerability assessment shall include, but not be limited 
     to, a review of pipes and constructed conveyances, physical 
     barriers, water collection, pretreatment, treatment, storage 
     and distribution facilities, electronic, computer or other 
     automated systems which are utilized by the public water 
     system, the use, storage, or handling of various chemicals, 
     and the operation and maintenance of such system. The 
     Administrator, not later than March 1, 2002, after 
     consultation with appropriate departments and agencies of the 
     Federal Government and with State and local governments, 
     shall provide baseline information to community water systems 
     required to conduct vulnerability

[[Page H9209]]

     assessments regarding which kinds of terrorist attacks or 
     other intentional acts are the probable threats to--
       ``(A) substantially disrupt the ability of the system to 
     provide a safe and reliable supply of drinking water; or
       ``(B) otherwise present significant public health concerns.
       ``(2) Each community water system referred to in paragraph 
     (1) shall certify to the Administrator that the system has 
     conducted an assessment complying with paragraph (1) prior 
     to:
       ``(A) December 31, 2002, in the case of systems serving a 
     population of 100,000 or more.
       ``(B) June 30, 2003, in the case of systems serving a 
     population of 50,000 or more but less than 100,000.
       ``(C) December 31, 2003, in the case of systems serving a 
     population greater than 3,300 but less than 50,000.
       ``(b) Emergency Response Plan.--Each community water system 
     serving a population greater than 3,300 shall prepare or 
     revise, where necessary, an emergency response plan that 
     incorporates the results of vulnerability assessments that 
     have been completed. Each such community water system shall 
     certify to the Administrator, as soon as reasonably possible 
     after the enactment of this section, but not later than 6 
     months after the completion of the vulnerability assessment 
     under subsection (a), that the system has completed such 
     plan. The emergency response plan shall include, but not be 
     limited to, plans, procedures, and identification of 
     equipment that can be implemented or utilized in the event of 
     a terrorist or other intentional attack on the public water 
     system. The emergency response plan shall also include 
     actions, procedures, and identification of equipment which 
     can obviate or significantly lessen the impact of terrorist 
     attacks or other intentional actions on the public health and 
     the safety and supply of drinking water provided to 
     communities and individuals. Community water systems shall, 
     to the extent possible, coordinate with existing Local 
     Emergency Planning Committees established under the Emergency 
     Planning and Community Right-to-Know Act (42 U.S.C. 11001, et 
     seq.) when preparing or revising an emergency response plan 
     under this subsection.
       ``(c) Guidance to Small Public Water Systems.--The 
     Administrator shall provide guidance to community water 
     systems serving a population of less than 3,300 persons on 
     how to conduct vulnerability assessments, prepare emergency 
     response plans, and address threats from terrorist attacks or 
     other intentional actions designed to disrupt the provision 
     of safe drinking water or significantly affect the public 
     health or significantly affect the safety or supply or 
     drinking water provided to communities and individuals.
       ``(d) Funding.--There are authorized to be appropriated to 
     carry out this section not more than $120,000,000 for the 
     fiscal year 2002 and such sums as may be necessary for fiscal 
     year 2003 and fiscal year 2004. The Administrator, in 
     coordination with State and local governments, may provide 
     financial assistance to community water systems for purposes 
     of compliance with the requirements of subsections (a) and 
     (b) and to community water systems for expenses and contracts 
     designed to address basic security enhancements of critical 
     importance and significant threats to public health and the 
     supply of drinking water as determined by a vulnerability 
     assessment under subsection (a).

     ``SEC. 1434. CONTAMINANT PREVENTION, DETECTION AND RESPONSE.

       ``(a) In General.--The Administrator, in consultation with 
     the Centers for Disease Control and, after consultation with 
     appropriate departments and agencies of the Federal 
     Government and with State and local governments, shall review 
     (or enter into contracts or cooperative agreements to provide 
     for a review of) current and future methods to prevent, 
     detect and respond to the intentional introduction of 
     chemical, biological or radiological contaminants into 
     community water systems and source water for community water 
     systems, including each of the following:
       ``(1) Methods, means and equipment designed to monitor and 
     detect chemical, biological, and radiological contaminants 
     and reduce the likelihood that such contaminants can be 
     successfully introduced into water supplies intended to be 
     used for drinking water.
       ``(2) Methods and means to provide sufficient notice to 
     operators of public water systems, and individuals served by 
     such systems, of the introduction of chemical, biological or 
     radiological contaminants and the possible effect of such 
     introduction on public health and the safety and supply of 
     drinking water.
       ``(3) Procedures and equipment necessary to prevent the 
     flow of contaminated drinking water to individuals served by 
     public water systems.
       ``(4) Methods, means, and equipment which could negate or 
     mitigate deleterious effects on public health and the safety 
     and supply caused by the introduction of contaminants into 
     water intended to be used for drinking water, including an 
     examination of the effectiveness of various drinking water 
     technologies in removing, inactivating, or neutralizing 
     biological, chemical, and radiological contaminants.
       ``(5) Biomedical research into the short-term and long-term 
     impact on public health of various chemical, biological and 
     radiological contaminants that may be introduced into public 
     water systems through terrorist of other intentional acts.
       ``(b) Funding.--For the authorization of appropriations to 
     carry out this section, see section 1435(c).

     ``SEC. 1435. SUPPLY DISRUPTION PREVENTION, DETECTION AND 
                   RESPONSE.

       ``(a) Disruption of Supply or Safety.--The Administrator, 
     in coordination with the appropriate departments and agencies 
     of the Federal Government, shall review (or enter into 
     contracts or cooperative agreements to provide for a review 
     of) methods and means by which terrorists or other 
     individuals or groups could disrupt the supply of safe 
     drinking water or take other actions against water 
     collection, pretreatment, treatment, storage and distribution 
     facilities which could render such water significantly less 
     safe for human consumption, including each of the following:
       ``(1) Methods and means by which pipes and other 
     constructed conveyances utilized in public water systems 
     could be destroyed or otherwise prevented from providing 
     adequate supplies of drinking water meeting applicable public 
     health standards.
       ``(2) Methods and means by which collection, pretreatment, 
     treatment, storage and distribution facilities utilized or 
     used in connection with public water systems and collection 
     and pretreatment storage facilities used in connection with 
     public water systems could be destroyed or otherwise 
     prevented from providing adequate supplies of drinking water 
     meeting applicable public health standards.
       ``(3) Methods and means by which pipes, constructed 
     conveyances, collection, pretreatment, treatment, storage and 
     distribution systems that are utilized in connection with 
     public water systems could be altered or affected so as to be 
     subject to cross-contamination of drinking water supplies.
       ``(4) Methods and means by which pipes, constructed 
     conveyances, collection, pretreatment, treatment, storage and 
     distribution systems that are utilized in connection with 
     public water systems could be reasonably protected from 
     terrorist attacks or other acts intended to disrupt the 
     supply or affect the safety of drinking water.
       ``(b) Alternative Sources.--the review under this section 
     shall also include a review of the methods and means by which 
     alternative supplies of drinking water could be provided in 
     the event of the destruction, impairment or contamination of 
     public water systems.
       ``(c) Funding.--There are authorized to be appropriated to 
     carry out this section and section 1434 not more than 
     $15,000,000 for the fiscal year 2002 and such sums as may be 
     necessary for fiscal year 2003 and fiscal year 2004.''.
       (2) Section 1414(i)(1) is amended by inserting ``1433'' 
     after ``1417''.
       (3) Section 1431 is amended by inserting in the first 
     sentence after ``drinking water'' the following: ``, or that 
     there is a threatened or potential terrorist attack (or other 
     intentional act designed to disrupt the provision of safe 
     drinking water or to impact adversely the safety of drinking 
     water supplied to communities and individuals), which''.
       (4) Section 1432 is amended as follows:
       (A) By striking ``5 years'' in subsection (a) and inserting 
     ``20 years''.
       (B) By striking ``3 years'' in subsection (b) and inserting 
     ``10 years''.
       (C) By striking ``$50,000'' in subsection (c) and inserting 
     ``$1,000,000''.
       (D) By striking ``$20,000'' in subsection (c) and inserting 
     ``$100,000''.
       (5) Section 1442 is amended as follows:
       (A) By striking ``this subparagraph'' in subsection (b) and 
     inserting ``this subsection''.
       (B) By amending subsection (d) to read as follows:
       ``(d) There are authorized to be appropriated to carry out 
     subsection (b) not more than $35,000,000 for the fiscal year 
     2002 and such sums as may be necessary for each fiscal year 
     thereafter.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Louisiana (Mr. Tauzin) and the gentleman from Michigan (Mr. Dingell) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Louisiana (Mr. Tauzin).


                             General Leave

  Mr. TAUZIN. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days within which to revise and extend their remarks 
and to insert extraneous material on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Louisiana?
  There was no objection.
  Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in strong support of the Public Health Security 
and Bio-terrorism Response Act of 2001 which I have introduced with my 
good friend, the gentleman from Michigan (Mr. Dingell) the ranking 
member of the Committee on Energy and Commerce and a strong bipartisan 
list of co-sponsors. This may be the last piece of legislation we 
consider tonight, Mr. Speaker,

[[Page H9210]]

 but it is, by far, the most serious one and the most important one, 
and we will be asking for a recorded vote tomorrow on this important 
legislation.
  The legislation is all about safety and security of American families 
and of our country. Today we are stepping up to the profound threats of 
terrorism and other public health emergencies. And we do so by 
combining smart and innovative policy with additional resources to 
prepare the country for bioterrorist threats and to improve our 
abilities to respond quickly and effectively to such threats when they 
arise.
  Mr. Speaker, let me be very specific about the important investments 
that this legislation will make and the dramatic range of issues it 
will address.
  First, Title I of the bill significantly steps up our preparedness 
and our capacity to identify and respond to threats. This Title will 
improve communications between and among the levels of government, 
public health officials, the first responders and health care providers 
and the health care facilities during emergencies.
  Our bill authorizes $1 billion in FY 2002 in grants to States, local 
governments, and other public and private health care facilities and 
other entities to improve planning and preparedness activities, to 
enhance laboratory capacity, and to educate and train the health 
personnel that will take care of folks who are subject to any kinds of 
such threats.
  We specifically authorized $40 million in FY 2002 for training grants 
to relieve shortages in critical health care professions. The 
Department of Health and Human Services will have a new focus, an 
improved coordination and accountability through a new assistant 
secretary of emergency preparedness. The legislation also authorizes 
the national disaster medical system, new planning and reporting 
provision, health professional verification systems during emergencies, 
the training exercises, and improved communication strategies. The bill 
further authorizes $450 million in FY 2002 for the Centers for Disease 
Control and Prevention to upgrade its capacity to deal with public 
health threats, to renovate its facilities and to improve its 
securities.
  H.R. 3448 will also ensure that we have sufficient drugs, vaccines 
and other supplies for our Nation's health security. Title I, for 
example, authorizes more than $1.1 billion for the Secretary of Health 
and Human Services to expand our current National stockpiles of 
medicines and other supplies, including the purchase of smallpox 
vaccines, will encourage and expand research and develop of drugs of 
vaccines and devices to combat bioterrorism and other potential disease 
outbreaks in our country. The bill also will enhance controls on deadly 
biological agents in order to help prevent bioterrorism and establish a 
national database of dangerous pathogens.
  Title II imposes new registration requirements on all possessors of 
the 36 most dangerous biological agents and toxins. It mandates tough 
new safety and security requirements to ensure that only legitimate 
scientists working in appropriate laboratory facilities can gain access 
to these potential weapons of mass destruction.
  Title II also enhances criminal penalties for those caught in 
possession of those agents or transferring them without proper 
registration. And Title III of the bill will help protect American 
safety in their food and drug supplies. We are increasing by $100 
million the Food and Drug Administration's resources to hire more 
inspectors at the border, to develop new methods to detect contaminated 
foods. In addition, we are providing the Secretary the additional 
regulatory authority he requested for the FDA to detain food and to 
investigate credible evidence of contamination and improve access to 
records and recordkeeping to assist the Secretary in investigating any 
threats to our food supply. This title also improves our enforcement 
and inspection capabilities for those drug supplies. The new resources 
and authorities will substantially improve our country's ability to 
ensure the safety confidence in both our food and our drug supplies.

                              {time}  2230

  Title 4 of the legislation will ensure that drinking water systems 
across the country assess their vulnerability to terrorist attack and 
develop emergency plans to prepare for and respond to those attacks. 
This title also requires a comprehensive review of the ways to detect 
and respond to chemical, biological, and radiological contamination of 
drinking water, as well as way to prevent and mitigate the effects of 
physical attacks. In addition, existing criminal penalties and fines 
for tampering with drinking water systems are substantially increased. 
A total of $170 million in fiscal year 2002 is authorized for these 
important efforts.
  Americans deserve to know that we are taking concerted action today 
to protect the water they drink every single day. Title IV will lay the 
groundwork for developing the necessary information, and emergency 
planning and response efforts that are needed to address this new 
threat.
  Mr. Speaker, this legislation builds on the tremendous work and 
leadership of our President, President Bush, and his administration, 
over the last 3 months. Importantly, it builds on existing programs 
rather than creating new ones that will only delay the distribution of 
monies to the front lines. We have spent time to integrate programs and 
to make sure our national efforts are focused and better coordinated. 
We have worked closely with the administration to achieve this result, 
and I am frankly very confident the President will sign this bill.
  I want to thank the gentleman from Michigan (Mr. Dingell) and the 
other members of the committee on both sides of the aisle for their 
tireless and extraordinarily good-faith efforts to produce a great 
bill. This is remarkable legislation, Mr. Speaker, for remarkable 
times. The House can be very proud not only of this product but also of 
a country that is responding in such a unified way as exemplified by 
the bipartisan spirit in which we bring this legislation to the floor.
  America, I think, will be proud of our commitment made in this bill 
to the right investments and the smart policy choices to meet the 
challenges and protect our Nation's public health. I urge all my 
colleagues to support this very landmark legislation.
  Mr. Speaker, I submit for the Record letters to and from the Chairman 
of the Committee on Science and myself regarding this legislation.

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                Washington, DC, December 11, 2001.
     Hon. Sherwood L. Boehlert,
     Chairman, Committee on Science, House of Representatives, 
         Rayburn House Office Building, Washington, DC.
       Dear Chairman Boehlert: Thank you for your letter regarding 
     H.R. __, the Public Health Security and Bioterrorism Response 
     Act of 2001.
       I appreciate your willingness not to seek a referral of the 
     bill. I agree that your decision to forgo action on the bill 
     will not prejudice the Committee on Science with respect to 
     its jurisdictional prerogatives on this or similar 
     legislation. Further, I recognize your right to request 
     conferees on those provisions within the Committee on 
     Science's jurisdiction should they be the subject of a House-
     Senate conference.
       I will include your letter and this response in the 
     Congressional Record when the bill is considered on the 
     Floor.
           Sincerely,
                                            W.J. ``Billy'' Tauzin,
     Chairman.
                                  ____

                                         House of Representatives,


                                         Committee on Science,

                                Washington, DC, December 11, 2001.
     Hon. W.J. Tauzin,
     Chairman, Committee on Energy and Commerce, Rayburn HOB, 
         Washington, DC.
       Dear Mr. Chairman: Earlier today you and your colleagues 
     introduced the ``Public Health Security and Bioterrorism 
     Response Act of 2001.'' Knowing of your interest in moving 
     the legislation through the House as quickly as possible, I 
     am prepared not to seek a sequential referral of the bill's 
     provisions that affect the jurisdiction of the Science 
     Committee. Despite waiving the right to seek a referral, the 
     Science Committee does not waive its jurisdiction over the 
     bill. Additionally, the Science Committee expressly reserves 
     its authority to seek conferees on any provisions that are 
     within its jurisdiction during any House-Senate conference 
     that may be convened on this legislation or like provisions 
     in the bill or similar legislation which falls within the 
     Science Committee's jurisdiction. I ask for your commitment 
     to support any request by the Science Committee for conferees 
     on the bill, as well as any similar or related legislation.
       Based on a quick review, here are some of the provisions I 
     believe affect the Science Committee's jurisdiction:
       Section 108 (Working Group on Preparedness). New 
     subsections (a)(1)-(3) require a joint working group, 
     including DOE and EPA, to coordinate and prioritize research,

[[Page H9211]]

     facilitate the development of countermeasures, and coordinate 
     research and development.
       Section 108 (Working Group on Preparedness). New subsection 
     (a)(4) requires the Working Group, including DOE and EPA, to 
     develop shared standards for equipment.
       Section 126 (Evaluation of New and Emerging Technologies). 
     Subsection (b) requires the Secretary of HHS to survey 
     existing technology programs funded by the Federal Government 
     for potentially useful technologies and, in consultation with 
     an interagency working group that includes DOE and EPA, to 
     evaluate technologies.
       Section 137 (Expanded Research by Secretary of Energy). 
     This authorizes DOE research related to bioterrorist attacks.
       Section 401 (Drinking Water Security and Safety). This 
     reauthorizes an existing environmental research and 
     development program in the Safe Drinking Water Act. Section 
     401 also authorizes two new programs, in proposed sections 
     1434 and 1435 of the SDWA, that direct EPA to ``review 
     current and future methods and means'' relating to 
     contamination and physical disruption of water systems. These 
     provisions are similar to provisions in the Science 
     Committee's bill, H.R. 3178.
       H.R. 3178 passed the Science Committee on November 15. It 
     authorizes EPA research related activities to develop anti-
     terrorism tools for water and wastewater agencies. Since our 
     markup of H.R. 3178, my staff has worked with your staff to 
     clarify the text of H.R. 3178 to prevent or reduce any 
     jurisdictional issues. I look forward to the continued 
     cooperation between our two Committees on both H.R. 3178 and 
     the ``Public Health Security and Bioterrorism Response Act of 
     2001.''
       I request that you include this exchange of letters in the 
     Congressional Record as part of the Floor debate on the bill.
       Thank you again for your consideration and attention 
     regarding these matters.
           Sincerely,
                                                Sherwood Boehlert,
                                                         Chairman.

  Mr. Speaker, I reserve the balance of my time.
  Mr. DINGELL. Mr. Speaker, I yield myself 3 minutes.
  (Mr. Dingell asked and was given permission to revise and extend his 
remarks.)
  Mr. DINGELL. Mr. Speaker, today we are considering bipartisan 
legislation on a matter of utmost national importance, our preparedness 
against terrorism. I want to begin by commending my good friend, the 
chairman of the committee, the gentleman from Louisiana (Mr. Tauzin), 
the gentleman from Florida (Mr. Bilirakis), and the gentleman from Iowa 
(Mr. Ganske), as well as my colleagues, the gentleman from Ohio (Mr. 
Brown), the gentleman from New Jersey (Mr. Menendez), and the gentleman 
from New Jersey (Mr. Pallone), the gentleman from Florida (Mr. 
Deutsch), who worked so hard on this, and the gentlewoman from 
California (Ms. Harman).
  This bill was put together in the best bipartisan traditions of the 
way the Committee on Energy and Commerce has always worked, and it 
resolves in the best possible way the questions that concern us with 
regard to preparedness and protection of our people against 
bioterrorism.
  There are many excellent provisions in the legislation, including 
improvement and protection of drinking water supply, tighter controls 
on dangerous biological agents, and a number of other things, including 
putting support where it needs to be put to help our people to address 
the problems which they have on the local level and to improve Federal-
local cooperation in these matters. It also does something very 
important, and that is it improves inspection resources for imported 
food.
  These are only a downpayment on what will ultimately be necessary, 
but nonetheless they are an enormous increase over the way things are 
done at this particular time.
  Mr. Speaker, I urge my colleagues, without exception, to support it. 
It is bipartisan, it is good, it is in the public interest; and I again 
commend my colleagues, including our chairman, for the fine work which 
has been done on this very difficult and very important piece of 
legislation.
  In addition, Mr. Speaker, I include for the Record a detailed 
explanation of the bill:
       Title III, Subtitle A--Protection of Food Supply, addresses 
     existing deficiencies in the Nation's food safety 
     infrastructure and takes appropriate steps to protect the 
     Nation's food supply from new threats of terrorism. In 
     particular, it authorizes new powers and $100 million to the 
     Food and Drug Administration (FDA) so it can increase and 
     improve inspections of imported food at the 307 different 
     U.S. ports of entry. With the additional funds and 
     authorities in this bill, FDA should be equipped to inspect 
     about 2 percent of all imported food shipments. While this 
     remains significantly less than FDA's recommendation to 
     inspect 10 percent of all imported food shipments, this 
     legislation is an important downpayment.
       The subtitle also provides for permissive debarment of 
     scofflaw food importers, requires prior notice of shipments, 
     provides administrative detention authority, requires 
     registration and recordkeeping, and bars port shopping. 
     Vigorous and targeted use of these new authorities should 
     enable the Secretary to mitigate problems caused by too few 
     inspectors.
       For example, under this subtitle the Secretary must possess 
     credible evidence or information indicating that a specific 
     shipment or article of food presents a serious health threat 
     to exercise his full detention authority. However, the bill 
     establishes a broader, less-stringent standard for the 
     Secretary to exercise a more limited temporary hold 
     authority. Under the temporary hold provision, the Secretary 
     need only have credible evidence or information indicating 
     that an article of food, not a specific article of food, 
     presents a serious health threat. If, for example, the FDA is 
     in possession of credible evidence or information indicating 
     that a category of food or food from a certain geographical 
     region presents such a threat, the Secretary may use this 
     authority to temporarily hold shipments or articles of food 
     (up to 24 hours) based on that information. This will enable 
     the Secretary to appropriately dispatch FDA resources to 
     gather credible evidence or information (based upon FDA 
     inspection, examination or investigation) about specific 
     shipments or articles of food. Once FDA has such evidence or 
     information, the Secretary may then detain any such shipments 
     or articles of food under the detention authority (up to 30 
     days). The temporary hold authority is intended to function 
     as an investigative tool that enables FDA to use its 
     detention authority, and its resources, more effectively. 
     Accordingly, the circumstances under which temporary hold 
     authority can be invoked are broader than those under which 
     detention authority can be invoked.
       Title III, Subtitle B--Protection of Drug Supply, includes 
     Section 312, which requires additional information regarding 
     import components intended for use in export products. This 
     section does not change any definitions of regulated articles 
     or the scope of regulation of those articles as set forth in 
     the Federal Food, Drug, and Cosmetic Act (FFDCA) and its 
     implementing regulations. Further, it is not the intent 
     of this section for the Secretary of Treasury to engage in 
     a new rulemaking to determine the requirement for bonds 
     for goods imported under section 801(d)(3) of the FFDCA. 
     Existing requirements for the bonding of goods imported 
     for further processing and export should be applied. 
     Finally, certificates of analysis are not required if the 
     only chemical or biological component of the good imported 
     under 801(d)(3) is de minimus, incidental, and poses no 
     danger to human or animal health.
       Title IV--Drinking Water Security and Safety, adds a new 
     section 1433 to the Safe Drinking Water Act that requires 
     community water systems to conduct assessments of the 
     vulnerability of its system to a terrorist attack. Sandia 
     National Laboratories, under a contract with the 
     Environmental Protection Agency (EPA), has developed a new 
     methodology for assessing and improving the security of 
     drinking water systems. Under Section 1433 vulnerability 
     assessments should include comprehensive site 
     characterizations, a determination of the consequences of 
     intentional acts or terrorist attacks, and an analysis of the 
     use, storage, or handling of various chemicals to see whether 
     a substitution to less dangerous chemicals will enhance the 
     safety and health of the public in the case of an attack. For 
     example, many drinking water systems are switching away from 
     liquid chlorine to other chemicals that minimize the risk of 
     an airborne toxic plume in case of a tank explosion. Further, 
     the term ``physical barriers'' should be interpreted to 
     include ``buffer zones'' to a physical attack.
       Section 1433 also requires that emergency response plans be 
     prepared or revised by community water systems after the 
     vulnerability assessments. In FY 2002, the bill authorizes 
     $120 million to assist water systems in conducting 
     vulnerability assessments and preparing emergency response 
     plans. This funding is available to also provide financial 
     assistance to water systems for basic security enhancements 
     and to address significant threats to public health. Basic 
     security enhancements of critical importance include 
     management systems, operating procedures, re-keying locks, 
     buffer zones, cameras, fencing, hardening of storage tanks, 
     equipment for back flow monitoring, security screening of 
     contractor support services, and intrusion alert systems.
       The bill charges the EPA, working with other agencies such 
     as CDC and the FBI, to provide water systems with a 
     consistent definition of the range of threats facing a 
     system. This will help ensure that quality vulnerability 
     assessments are conducted.
       Title IV also contains amendments to Section 1432 of the 
     Safe Drinking Water Act to increase the criminal penalties 
     for tampering or threatening to tamper with a public drinking 
     water system.
       Finally, the bill amends Section 1431 of the Safe Drinking 
     Water Act to provide new authority to the Administrator to 
     take actions to assure the safety of the public and protect 
     supplies of drinking water in circumstances

[[Page H9212]]

     of a threatened or potential terrorist attack at a community 
     water system which may present an imminent and substantial 
     endangerment to the health of persons.
       The term ``potential terrorist attack'' should be 
     interpreted in the context of the President's announcements 
     that the United States is engaged in a war against terrorism 
     and faces ``continuing and immediate threats of further 
     attacks.'' Senior government officials have repeatedly warned 
     that critical infrastructure facilities should remain on a 
     high state of alert due to the possibility of a terrorist 
     attack. Critical infrastructure protection is an issue of 
     importance to economic and national security. Presidential 
     Decision Directive 63 released in May 1998 identified water 
     supply as one of the 12 areas critical to the functioning of 
     the country.
       The Government has a responsibility to protect our 
     citizens, and that responsibility begins with homeland 
     security. Where the Administrator receives information that 
     critical community water system infrastructures, such as a 
     utility pumping system or chemical storage tanks, are 
     vulnerable to potential terrorist attack that may present an 
     imminent and substantial endangerment he or she may use the 
     authority provided by Section 1431 to protect the health and 
     safety of the public or prevent the disruption of drinking 
     water supplies.

  Mr. Speaker, I reserve the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I am pleased to yield 3 minutes to the 
gentleman from Florida (Mr. Bilirakis), the chairman of the 
Subcommittee on Health of the Committee on Energy and Commerce.
  Mr. BILIRAKIS. Mr. Speaker, I thank the gentleman for yielding me 
this time, and I too rise in support of this bill.
  As we know, today is the 3-month anniversary of the worst terrorist 
attack on American soil in history. Our thoughts and prayers are with 
the victims and their families today and every day. I share the 
concerns, we all share the concerns of all Americans who are worried 
about future terrorist activities, including bioterrorist attacks. With 
the recent anthrax outbreak, bioterrorism of course has become a 
reality.
  Bioterrorism is an issue that has been explored by the Committee on 
Energy and Commerce and my Subcommittee on Health for several years. 
Because we cannot know when or how a public health threat might occur, 
we must be prepared to combat any biological agent in any form. I am 
pleased that we were able to work on a bipartisan, underline 
bipartisan, basis to craft this reasonable and responsible legislative 
package.
  State and local governments will be the first to respond to a 
bioterrorist attack. This legislation requires the Secretary of Health 
and Human Services to work with local governments to develop 
bioterrorist preparedness plans. This legislation requires the CDC to 
enhance training of personnel, improve their communications network and 
intensify security to protect important research and dangerous 
pathogens.
  Since health care providers will be the first to respond to a public 
health emergency, it is essential that we have health professionals 
ready to deal with health care needs in the event of a bioterrorist 
attack. This legislation begins to address shortages in areas such as 
medical technologists and pharmacists by providing grants to train and 
educate individuals in areas of the greatest need.
  As vice chairman of the House Committee on Veterans' Affairs, I also 
believe it is essential that we fully utilize all of our Federal 
resources in our fight against bioterrorism. This legislation requires 
the Department of Health and Human Services to work with the Department 
of Veterans Affairs and the Department of Defense in developing our 
national response. These agencies have significant resources and 
expertise and are crucial to our efforts.
  In addition, this legislation increases the protection of the 
Nation's food supply. In the past, too few resources have been 
dedicated to food security, and this legislation is a great 
improvement. Secretary of Health and Human Services Tommy Thompson 
recently testified before the committee that the Food and Drug 
Administration must increase the number of inspectors at the borders.
  I would like in closing, Mr. Speaker, to thank the staff, who 
dedicated many long hours to developing this legislation. For the 
majority, that includes Nandan Kenkeremath, Tom DiLenge, Amit Sachdev, 
Brent DelMonte, Bob Meyers, and Pat Morrisey. From the minority, that 
includes John Ford, Edith Holleman, and Bruce Gwinn. And I would also 
like to extend a special thank you to legislative counsel Pete Goodloe, 
who was instrumental in drafting this legislation. All of the staff, 
all of them, spent countless hours, especially over the Thanksgiving 
holiday, to prepare this vital legislation.
  I too urge our colleagues to join us in supporting this bill. It is 
important that we act this year to increase our readiness and our 
safety.
  Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the gentleman from 
Ohio (Mr. Brown).
  Mr. BROWN of Ohio. Mr. Speaker, I thank the gentleman for yielding me 
this time; and I am pleased to join my colleagues, the gentleman from 
Michigan (Mr. Dingell), the gentleman from Louisiana (Mr. Tauzin), the 
gentleman from Florida (Mr. Bilirakis), the gentleman from New Jersey 
(Mr. Pallone), and the gentleman from Florida (Mr. Deutsch), in 
offering this bipartisan bioterrorism preparedness bill.
  I want to thank the Committee on Energy and Commerce staff, who 
worked so hard on this bill, as mentioned by the gentleman from Florida 
(Mr. Bilirakis), including Ann Esposito, John Ford, Dave Nelson, Edith 
Holleman, and Bruce Gwinn. Also, legislative counsel Pete Goodloe, who 
worked so very hard on all of this.
  The events of September 11 and the recent spate of anthrax attacks 
have significantly underscored the importance, to be sure, of our 
Nation's public health infrastructure. We need to pay far more 
attention to the first responders to a public health emergency, to the 
key health agencies charged with addressing and preventing these 
emergencies, and to the safeguards needed to minimize threats in the 
future.
  We must have sufficient antibiotic and vaccine stockpiles, we must 
have the ability to rapidly distribute medical supplies and deploy 
medical personnel, and we must cultivate the expertise and technology 
necessary to identify and eliminate threats before they become public 
health crises.
  This bill was written to provide new authority to Food and Drug 
Administration border inspectors in terms of food safety, to require 
the development of rapid testing techniques, and to authorize $100 
million of new found for all of FDA's border inspection activities. 
These provisions will increase FDA's presence at the border and allow 
for the inspection of a greater percentage of our imported foods, 
making our food supplies safer from bioterrorists.
  Eight years ago, before budget cuts in this Congress, 8 percent of 
food was inspected at the border. Today, it is about one-tenth of that. 
It is less than 1 percent. The safety of imported foods and the need 
for greater enhanced inspection resources at the border have long been 
a concern of many of us on this side of the aisle, a fact highlighted 
by the imported food safety bills I have introduced with the gentleman 
from Michigan (Mr. Stupak), the gentleman from New Jersey (Mr. 
Pallone), and the gentleman from Michigan (Mr. Dingell), and others 
during the past several sessions of Congress.
  The food safety provisions of this bill are a good downpayment on 
improving our food safety inspection system, but they do not obviate 
the need for passage of a more substantial food safety reform like the 
one we introduced in October.
  I am pleased that a provision to equip State and local health 
departments to rapidly identify antibiotic resistant strains of illness 
was in fact included in the bill. Because antibiotic resistant microbes 
can be difficult to treat, even under normal circumstances, they pose a 
significant threat to public health. We know that antibiotic-resistant 
strains of anthrax and other agents can, in fact, have been engineered 
for the purposes of bioterrorism. A new or unexpected antibiotic-
resistant strain of illness is a red flag. It could signal a 
bioterrorist attack. So the sooner we identify it, the sooner we can 
deploy the resources needed to treat it.
  The ability to monitor antibiotic resistance becomes even more 
critical over the longer term. Whether the goal is bioterrorism 
preparedness or simply maintaining our ability to combat everyday 
illnesses and infectious disease, a major, major function of the 
Centers for Disease Control, we simply cannot

[[Page H9213]]

assess the adequacy of our antibiotic supply over time as long as 
antibiotic resistance remains a variable.
  This bill is not the last word on bioterrorism, but it is a solid 
first step; and I am proud to be one of its chief cosponsors.
  Mr. TAUZIN. Mr. Speaker, I am proud to yield 2 minutes to the 
gentleman from North Carolina (Mr. Burr), the vice chairman of the 
Committee on Energy and Commerce and the chairman of the task force 
which helped produce this bill.
  Mr. BURR of North Carolina. Mr. Speaker, I thank the chairman for 
yielding me this time, I also thank the ranking member; but more 
importantly, I thank all the members of the Committee on Energy and 
Commerce because traditionally we do not get things done as quickly in 
the body as we have on this bill.
  I want to take this opportunity to personally thank the staff on both 
sides of the aisle, many of whom are here tonight, and many who spent 
tens, if not hundreds, of hours on this bill, and much of it over the 
Thanksgiving break.
  Mr. Speaker, 3 months ago, we were attacked in a savage way. Over 
these 3 months, we have seen what is good about America; the response 
of the American people, in many cases to individuals they did not know. 
What we have seen good about this institution is its ability to throw 
down the partisanship that sometimes overtakes us and for Democrats and 
Republicans to work together on an initiative that America needs today.
  We have come a long way in restructuring our public health agencies 
in this country. This is only the first step, though. We have a long 
way to go to reach a point that communities deserve for us to have in 
place. Through this legislation we strengthen our Federal disaster 
response efforts by authorizing in law the National Disaster Medical 
System.
  This legislation provides for the much-needed resources to improve 
the Centers for Disease Control, not only the facilities upgrade that 
is needed in Atlanta, but also an additional $150 million in the first 
year to make sure that the overuse of laboratories, the space needs, 
everything that they need to respond to a threat that we clearly do not 
fully understand today are in fact in place.
  We send money directly to States and to local public health agencies 
in order for them to build out their core capacity to deal with 
bioterrorism and other public health threats.
  Mr. Speaker, in this, we update and strengthen the pharmaceutical 
stockpiles, and we establish a core educational curriculum to train 
health care professionals for public health emergencies.
  I urge all of my colleagues to support this legislation today, but we 
cannot quit until the public health network in the U.S. is trained, 
equipped, and prepared to handle all responses and all threats in the 
future.
  Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the gentleman from New 
Jersey (Mr. Pallone).
  Mr. PALLONE. Mr. Speaker, I come to the House floor also to offer my 
support for this crucial piece of legislation; and again I want to 
thank our ranking member, the gentleman from Michigan (Mr. Dingell), 
and the ranking member of the subcommittee, the gentleman from Ohio 
(Mr. Brown), and the gentleman from Florida (Mr. Deutsch), and all the 
staff that I see here tonight who worked so hard on this bill, and 
stress the importance of the bill.

                              {time}  2245

  When the terrorist attacks against the World Trade Center and the 
Pentagon took place on September 11, I know that my constituents in 
particular and all Americans were concerned about possible threats from 
biological and chemical warfare that might follow. On September 28, the 
General Accounting Office published a report that stated, in fact, our 
health departments are ill-equipped, that we are vulnerable to 
bioterrorism and underfunded on the Federal, State and local level.
  Mr. Speaker, I believe that this bill will remedy this problem in a 
crucial way. I want to discuss briefly the water security component of 
the bill. With the strong leadership of the gentleman from Louisiana 
(Mr. Tauzin) and ranking member, the gentleman from Michigan (Mr. 
Dingell), we were able to include language requiring large water 
systems serving more than 3,300 persons to conduct a vulnerability 
assessment and prepare or update emergency response plans within 6 
months after the completion of the vulnerability assessment. In the 
process of completing this assessment, serious consideration would be 
given to the potential consequences of attack.
  For example, what would happen if the on-site chlorine tanks are 
attacked with explosives? Should safer substitutes for liquid chlorine 
be used? What are the health risks to the public if we are faced with 
an air-borne toxic chlorine cloud?
  These are the types of questions that need to be evaluated and 
answered in a vulnerability assessment.
  In addition to the assessment, I was pleased that funding was 
authorized in the bill to provide for technical assistance grants from 
EPA and funding for publicly owned water systems in an emergency 
situation. I do not have to explain the importance of protecting the 
public from potential disruption of water service or biological-
chemical contamination of drinking water supplies. Water security has 
got to be a top priority in any bioterrorism bill that Congress 
considers.
  On September 12, President Bush made a comment. He said America is 
going forward, and as we do so, we must remain keenly aware of the 
threats to our country. Those in authority should take appropriate 
precautions to protect our citizens. And according to this bill, Mr. 
Speaker, the EPA will have that authority that the President referred 
to if an assessment is completed and there is sign of significant 
vulnerability, it is a relief to know that the EPA, using its emergency 
powers, will be able to work with the community water systems to 
promptly correct the inadequacies.
  I know that the gentleman from Louisiana (Mr. Tauzin) and the 
gentleman from Michigan (Mr. Dingell) worked hard to make sure that 
this safe drinking water component is in the bill. I think it is very 
important that it is in the bill, and I congratulate them and the staff 
again for making sure that this is a part of the bioterrorism response.
  Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentleman from Iowa 
(Mr. Ganske), a distinguished member of our committee.
  Mr. GANSKE. Mr. Speaker, I am pleased to support this bill. My 
congratulations to the chairman of the committee and to the ranking 
member. This is probably one of the more significant public health 
pieces of legislation that Congress has done in a long time and we need 
to do it. As a physician, I can tell Members this country is not able 
to handle an epidemic. There are very few hospitals, if any, in this 
country that can handle an epidemic, and that includes Johns Hopkins or 
the University of Iowa Hospital.
  This bill provides funding to begin to bolster our public health 
response to a bioterrorist attack. We need to provide more funds for 
medicines and vaccines. We need to bolster the CDC. We need to 
facilitate communications between the Federal Government, the State 
governments, local governments. Those things are handled in this bill.
  There is a lot in this bill that is very necessary and important. The 
one thing that was a concern earlier in the discussion on this bill was 
whether Members provide block grants or grants back to the States. I 
introduced, along with the gentleman from Arkansas (Mr. Berry) a few 
weeks ago. We had about a billion dollars for that. We think that is 
important because a lot of States are strapped for cash, and they need 
some help. That is in this bill as well. I very much appreciate the 
efforts of the chairman and the ranking member, the staff, for this 
bill.
  In essence, the bill that I introduced a couple of weeks ago and this 
bill are very similar. This is a bipartisan bill. It is a bicameral 
bill. It is my understanding that the administration is in favor of 
this bill. This bill should move. I encourage all Members of the House 
to vote for the bill, and for the Senate to do the same so we can move 
it to the President's desk.
  Mr. DINGELL. Mr. Speaker, I yield 3 minutes to the gentleman from 
Florida (Mr. Deutsch).

[[Page H9214]]

  Mr. DEUTSCH. Mr. Speaker, I join my colleagues in thanking the 
chairman of the full committee and the ranking member as well, as well 
as our excellent staff on both sides.
  This bill is a product of the entire House, and particularly the 
Committee on Energy and Commerce can be very proud of. This legislation 
very well might go down as the very most important piece of legislation 
that this Congress passes in this session. It has not gotten the most 
attention at this point in time, and I hope what it tries to prevent 
does not get as much attention because in a sense that would mean a 
success.
  But I highlight some of the issues that we are facing, and really the 
world obviously changed, each of our lives changed, America changed on 
September 11. This bill is a step towards dealing with some of those 
changes. The budgeting that we had in the past, literally in the past 
year, in last year's fiscal year, amounted to approximately $100 
million towards bioterrorism. This bill now raises that level to 
effectively about $3 billion. Obviously, an incredibly dramatic 
increase.
  I think there have been Members who have expressed a viewpoint, and 
in a sense I share it, maybe that number should even be larger. Even 
$30 billion, an order of magnitude different than hopefully what we 
will appropriate and authorize in this legislation. But as we work 
towards that, it is a question whether or not the agencies could even 
deal with this large of an increase, but to that other level I am not 
sure it would be possible.
  Let me focus on one of the areas where this bill is going to have a 
very significant effect, and that is the threat of biological terrorism 
in the United States. The bill specifically authorizes $450 million for 
smallpox vaccine, requires the Secretary to devise a plan for the 
distribution of the national stockpile, including the smallpox vaccine. 
The Secretary can designate priority countermeasures as fast track 
products for FDA approval. It requires the FDA to issue a final rule 
allowing for animal studies to prove efficacy of certain vaccines and 
drug countermeasures, and the secretary can award grants or contracts 
for research to develop new vaccines, treatments or therapies to 
counteract bioterrorist agents.
  Mr. Speaker, we have shifted the emphasis far greater and far more 
than we had in the past, and this is exactly the response we should be 
doing. Along with many of my colleagues, I have visited CDC since 
September 11. They cry out for the need that this bill specifically is 
addressing. Mr. Speaker, I urge my colleagues to support adoption of 
the legislation.
  Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
New Mexico (Mrs. Wilson).
  Mrs. WILSON. Mr. Speaker, I commend the chairman and ranking member 
for their work on this bill. Sometimes we do things quickly and quietly 
in this House and get important things done; and probably in the last 3 
months, this legislation will stand the test of time as one of the most 
important pieces of legislation that we do in this House during this 
session.
  What it is about is protecting Americans from getting sick or dying 
from a disease spread intentionally by people who want to destroy us. 
It is a very new world, and we have to change the way that we do things 
because the world has changed, and be better prepared so we can detect 
disease sooner, we can respond sooner and more effectively, and we can 
develop new cures for diseases that are now being genetically 
engineered by people who have evil intent.
  Mr. Speaker, in the last 3 months, we have learned that our 
laboratory system is fragile and can be easily overwhelmed by two 
relatively small but frightening anthrax attacks here on the East 
Coast; and that the Centers for Disease Control are not large enough 
and need to be modernized. We need to expand and integrate that 
national network of capacity in our laboratories and our research 
institutions. We need to invest in research and development to develop 
new ways to detect pathogens in the air, in the water, in food, and 
detect them quickly without having to wait for someone to get sick 
before we act.
  We do not have a register of the dangerous pathogens in this country. 
We did not know which laboratories have this particular strain of Ames 
anthrax. We need to register them, and also have cultures of them so 
that we know the DNA of each pathogen that is being used in the United 
States for research. This is a very good bill, Mr. Speaker. I am proud 
to support it, and I look forward to its prompt passage in this House 
and in the United States Senate.
  Mr. DINGELL. Mr. Speaker, I reserve the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentleman from 
Georgia (Mr. Linder), who was the principal sponsor of a separate piece 
of legislation to expand and improve upon the capacities of the CDC.
  (Mr. Linder asked and was given permission to revise and extend his 
remarks.)
  Mr. LINDER. Mr. Speaker, this is a remarkable feat to move a piece of 
legislation so important so fast and so well done, and I congratulate 
the gentlemen. I particularly thank the gentleman from North Carolina 
(Mr. Burr) who headed up the task force to ensure that my bill, H.R. 
3219, wound up in this bill.
  My bill reauthorized the rebuilding of the CDC $300 million for 2 
years in a row and multiyear contracting. Let me tell Members about the 
CDC. It is a 55-year-old institution, the largest institution of the 
Federal Government not located in the metro area here. It is a world 
class intellectual community in a third world facility. Many Members 
have visited it.
  The CDC facility needs to be upgraded, particularly the security 
around it. We have dangerous bugs and viruses there that are being 
stored three stories above the loading dock. We need to do this. I am 
grateful for Members' response, and I am sure that the Senate will 
respond equally. The Secretary of HHS is in favor of this bill. It is 
not common in my 27 years in public life that we can introduce a bill 
on November 1 and have it voted on December 11. I am grateful for this 
bill.
  Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentleman from New 
Jersey (Mr. Smith).
  Mr. SMITH of New Jersey. Mr. Speaker, I rise in strong support of 
H.R. 3448. As chairman of the Committee on Veterans Affairs, I am 
pleased that the legislation recognizes the vital role that the 
Department of Veterans Affairs can and should play in helping our 
Nation prepare for future biological attacks.
  As many Members know, the VA owns and operates the largest integrated 
health care network in the world, consisting of 172 medical centers, 
over 800 outpatient clinics, and 90 major research programs and are 
ideally suited to try to work, in collaboration with other agencies of 
government, on trying to respond to one of these terrorist attacks.
  I would also point out to Members that the anthrax letters originated 
in my district in Trenton and Hamilton Township, New Jersey. And as all 
of the different bodies came together, CDC, Department of Health and 
the others, the VA stood ready and was able to provide, if it was 
necessary, Cipro and other antibiotics, because they are a major 
stockpiling of those pharmaceutical assets. I am happy that the 
chairman include in section 101(c) a requirement for the Secretary of 
Health and Human Services to evaluate the feasibility of using 
biomedical research and development capabilities of the VA in 
developing a comprehensive national response to bioterrorist attacks.

                              {time}  2300

  Again, the VA is ideally suited for this. I have introduced a number 
of bills that would try to further that. I think we really need to make 
sure that they have a very prominent seat at the table.
  Mr. DINGELL. Mr. Speaker, I yield myself such time as I may consume.
  All the Democrats have agreed with me this is a superb piece of 
legislation and they have all gone home to bed so that they could vote 
on it tomorrow.
  Mr. Speaker, I yield back the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume.
  Let me conclude by thanking my dear friend, the gentleman from 
Michigan (Mr. Dingell), for the extraordinary cooperation shown on this 
bill. Speakers have said this before, but I want to emphasize this: 
this may be

[[Page H9215]]

the most important thing we conclude in terms of important legislation 
for our country's sake as we wind down this session before Christmas. 
It is our intent to take a vote on this tomorrow and hopefully ask the 
other body to move on it very quickly.
  Ms. JACKSON-LEE of Texas. Mr. Speaker, I would also like to thank 
House Energy and Commerce Committee Chairman Billy Tauzin and Ranking 
Member John Dingell for this important bi-partisan legislation, H.R. 
3448, so that we can fulfill our promise to the American people in 
terms of preparedness against bioterrorism.
  For weeks, the House Energy and Commerce Committee worked tirelessly 
to strengthen our public health infrastructure at the national, state 
and local levels to better protect our Nation and our people. This 
legislation is the fruit of those efforts.
  As a Member of the Homeland Security Task Force and as Vice-Chair of 
the Domestic Law Enforcement Working Group, I fully appreciate and 
respect the legislative effort before us. This balanced legislation, 
while by no means a complete fix to our problem of bioterrorism and 
homeland security, is an excellent beginning.
  The Act broadly authorizes funds for planning, preparation, and 
response, and places particular emphasis on the state and local level. 
Importantly, the resources provided in this Act will go directly to 
those in the front lines who need them the most.
  Specifically, the Act authorizes more than $1 billion in grants to 
states, local governments, and other public and private health care 
facilities and other entities to improve planning and preparedness 
activities, enhance laboratory capacity, educate and train health care 
personnel, and to develop new drugs, therapies, and vaccines.
  The Act authorizes $450 million for the Centers for Disease Control 
and Prevention to upgrade their own capacities to deal with public 
health threats, to renovate their facilities and to improve their 
security. It also authorizes more than $1 billion for the Secretary of 
Health and Human Services to expand our current national stockpiles of 
medicines and other supplies, including the purchase of additional 
smallpox vaccines.
  The Act also establishes a national database of dangerous pathogens, 
and imposes new registration requirements on all possessors of the 36 
most deadly biological agents and toxins and mandates tough new safety 
and security requirements.
  Furthermore, the Act contains new protections for our Nation's food 
supply by increasing by $100 million FDA resources to enable the 
Secretary to hire more inspectors at our borders and develop new 
methods to detect contaminated foods.
  Finally, the Act provides greater protections against chemical, 
biological or radiological attacks on our drinking water by authorizing 
over $100 million for the development of vulnerability analyses and 
emergency response plans for our drinking water systems.
  This legislation is greatly needed now. As Members of Congress, 
entrusted with the security of our great Nation, our greatest 
responsibility is to provide the tools needed to get the job done. This 
legislation does that.
  I urge my colleagues to support it.
  Mrs. McCARTHY of Missouri. Mr. Speaker, I rise in favor of the Public 
Health Security and Bioterrorism Response Act of 2001. In the three 
months since September 11, Congress has passed important legislation, 
including an Emergency Supplemental Appropriations package, an airline 
safety bill, and the war powers resolution to assist in the recovery, 
rebuilding, and protection of our homeland. The Public Health Security 
and Bioterrorism Response Act will contribute to the protection of our 
country and is critical to preparing the first responders for 
biological and chemical events.
  This fall, I have held two conversations with the community in Kansas 
City. More than 250 citizens, including police, fire, emergency 
medical, public health, and government officials exchanged important 
ideas on how to secure proper communication systems for emergency 
response action in the event of a crisis. These first responders 
expressed that the current public health resources are not sufficient 
to protect the city in the face of a bioterrorist attack. The Public 
Health Security and Bioterrorism Response Act of 2001 authorizes $2.69 
billion for national, state, and local efforts to be prepared for 
bioterrorism and other public health emergencies. This bill will 
provide money to the local communities and will give them the 
flexibility they desire in determining its use. Section 106, amending 
Section 319H (a), page 33, states that ``the Secretary may make awards 
of grants and cooperative agreements to appropriate public and 
nonprofit private health or education entities . . . for the purpose of 
providing low-interest loans, partial scholarships, partial 
fellowships, revolving loan funds, or other cost-sharing forms of 
assistance for the education and training of individuals in any 
category of health professions for which there is a shortage that the 
Secretary determines should be alleviated in order to prepare for or 
respond effectively to bioterrorism and other public health 
emergencies.''
  This legislation is specifically designed for the first responders. 
As it states in Section 108, this law will protect those who ``Respond 
to a bioterrorist attack, including the provision of appropriate safety 
and health training and protective measures for medical, emergency 
service, and other personnel responding to such attacks.
  In a bistate community such as the metropolitan Kansas City Area a 
community wide response is needed to protect our citizens. Fortunately 
in my community, the Mid America Regional Council's Metropolitan 
Medical Response System (MMRS) is a role model for our nation to 
follow. In light of the horrific attacks on our country and the ongoing 
biological and chemical threats facing our citizens this bill addresses 
the needs of a metropolitan area through Sec. 108, page 40, line 6, 
``(A) developing community wide plans involving the public and private 
health care infrastructure to respond to bioterrorism or other public 
health emergencies, which are coordinated with the capacities of 
applicable national, State, and local health agencies.''
  These resources are essential in building our public health 
infrastructure and will allow for not only the upgrading of the Centers 
of Disease Control and Prevention and the purchase of the smallpox 
vaccine, but also grants for local communities to develop and implement 
emergency plans, the education of health care personnel, and the 
continuation of state and local preparedness activities. Due to this 
legislation, local governments across the country will receive 
increased funds and will be better prepared to meet their communities' 
public health needs.
  Protection of the food supply and the security and safety of our 
drinking water are national concerns that are also addressed in this 
comprehensive bill. These include assessments of the threats to the 
food and water supplies, increased inspection of imported food, 
improved information management systems, and the development of rapid 
detection inspection methods. The Public Health Security and 
Bioterrorism Response Act of 2001 once implemented by our local public 
health and safety authorities will help to alleviate the fears of 
contamination of our food and water supplies.
  Thank you Chairman Tauzin and Ranking Member, Mr. Dingell, for 
constructing this bipartisan bill. I fully support the passage of this 
legislation and am confident that it will contribute to the 
amplification of the public health infrastructure and local 
bioterrorism preparedness.
  Mr. MARKEY. Mr. Speaker, I rise in support of the Public Health 
Security and Bioterrorism Response Act of 2001. This strong bipartisan 
effort increases funding for important public health response in the 
event of a bioterrorist attacks, and ultimately will help thousands of 
lives beyond those potentially threatened by bioterrorism. Today 
bioterrorism calls us to arms--but let us not forget that improving the 
public health system serves to protect against the more common but 
equally devastating threat of infectious disease--these illnesses end 
the lives of thousands of Americans daily and continue to be the third 
leading cause of death in the United States. This bill is a positive 
step forward in addressing this ongoing problem by improving our 
currently underfunded public health system.
  I am especially pleased that the bill includes provisions aimed at 
increasing stockpiles of potassium iodide as a public health response 
in the event of a successful terrorist attack on or accident at a 
nuclear power plant as well as provisions establishing new registration 
requirements and new rules limiting access to, and improving usage 
procedures for ``select agents.''
  Potassium iodide is to radiation exposure of the thyroid what Cipro 
is to Anthrax. Since potassium iodide must be taken within a few hours 
of exposure to radioactive iodine to be effective, it needs to be 
easily obtained by the people who live close to a nuclear reactor. 
While this provision doesn't go as far as I would personally prefer, it 
represents a good first step towards distributing stockpiles of this 
substance to local public health officials without requiring a formal 
request from the States. I look forward to improving this provision as 
this bill moves through the legislative process.
  Under the compromise provision I worked out with the sponsors of this 
bill, the Secretary of Health and Human Services would be required to 
make potassium iodide available to State and local governments for 
stockpiling and distribution to public facilities, such as schools and 
hospitals, within 20 miles of every nuclear power plant in the United 
States. Potassium iodide has been proven to protect the thyroid gland 
from diseases caused by exposure to radioactive iodine released during 
a nuclear catastrophe. Children are most vulnerable to radiation-
induced thyroid diseases because their thyroid glands are very active. 
To receive the drug, State and local governments

[[Page H9216]]

must submit a plan for distribution and utilization of the tablets in 
the event of a nuclear incident. While I personally would like to see 
much larger stockpiles that would cover populations even further from 
the reactor, funding limitations and other factors did not make that 
possible at this juncture. I remain hopeful, however, that we can build 
on this first step so that we have a strong, public-health based 
program in place that assures that all citizens that may need potassium 
iodide in a crisis will be able to get it in a timely fashion.
  I also applaud the inclusion of other provisions amending a 1996 
bioterrorism law I had co-authored which required facilities that 
transfer potentially lethal biologic agents to register with the 
Centers for Disease Control (CDC). Today's bill expands the 
requirements for registration with the CDC by requiring all facilities 
that possess any one of a series of select agents to register with the 
CDC and establishes new criminal offenses involving the handling of 
these agents.
  The Public Health Security and Bioterrorism Act of 2001 is a strong, 
bipartisan step towards protecting the public from the threat of 
bioterrorism or nuclear terrorism. I urge your support of this bill.
  Mr. BUYER. Mr. Speaker, I rise in support of the Public Health 
Security and Bioterrorism Response Act. This legislation will 
strengthen our ability to conduct a war against terrorism, whether with 
biological, chemical, or radiological agents.
  I am particularly pleased that this legislation contains a version of 
legislation I introduced to provide health professionals with access to 
the very best information we have for treatment of injuries or diseases 
from weapons of mass destruction or natural disasters. Our health care 
professionals are not resourced or trained with the proper tools to 
detect, diagnose, and treat casualties in the face of biological, 
chemical and radiological weapons.
  The very best information we have for medical treatment of injuries 
or diseases as a result of these weapons currently resides with the 
Department of Defense and the Department of Veterans Affairs. There is 
no need to reinvent the wheel with regard to medical knowledge on 
weapons of mass destruction. It currently resides with the federal 
government. We have an obligation to get this information into the 
hands of all medical professionals who need it.
  Section 105 of this bill directs the Secretary of Health and Human 
Services to develop and provide educational material to health 
professionals for the response to weapons of mass destruction. The 
Department of Defense and Department of Veterans Affairs have seats at 
the table with the Secretary in this program.
  It is my intent with this Section that the educational material and 
curriculum that already exist within DOD and VA be adapted and provided 
to health professionals in civilian settings. We cannot afford to 
assume that our country will never have to experience a massive 
biological, chemical, or radiological attack. The combination of DOD's 
expertise in the field of treating casualties resulting from an 
unconventional attack and the VA's infrastructure of 171 medical 
centers, 800 clinics, satellite broadcasting capabilities and a 
preexisting affiliation with 107 medical schools should enable current 
and future medical professions in this entire country to become 
knowledgeable and medically competent in the treatment of casualties of 
weapons of mass destruction.
  Health care providers all across the country are not looking for 
anthrax, botulism, smallpox, and other such diseases. You do not 
diagnose what you have not been training to see. Now medical 
professionals will be trained to see and treat injuries or diseases 
from unconventional sources.
  Let me also take a moment to explain what this provision does not do. 
It does not establish a federal curriculum for medical schools. It does 
not mandate that medical schools teach particular educational material. 
It does not set any new community standard with regard to health care 
and practice.
  What I am interested in doing is sharing the information that is 
readily available through DOD and the VA with the civilian health care 
community. Our civilian health care system must develop effective, 
practical responses to these deadly weapons. It must do this through 
planning, training, preparation for future terrorist attacks. Section 
105 will help.
  Mr. Speaker, I would also like to briefly express my view regarding 
Title III of this bill, which addresses the security of our food, 
especially imported food. While I am pleased that this legislation pays 
special attention to the security of our food sources, let me be clear 
that I will encourage the Secretary of HHS to exempt small businesses, 
and farms from the registration or the recordkeeping requirements of 
Title III. While I understand the bill exempts farms from 
recordkeeping, I do think that it is not necessary for American farmers 
to register with the Secretary of HHS as suppliers of food. 
Furthermore, I do not think that small retail food establishments, 
those in smaller rural communities, or those that serve a particular 
niche in a larger community should be required to register. To me, this 
is common sense, and I will be urging this approach to the Secretary.
  This is a good measure that the Committee has worked very hard to 
produce and I urge the passage of the bill.
  Mr. GILLMOR. Mr. Speaker, I rise in support of this anti-terror 
legislation and urge all my colleagues to vote in support of it.
  Three months ago, to the date, our country was reminded that freedom 
is not free. It is a painful lesson, but one from which we have learned 
in the past and one we should never forget.
  On one of the buildings here in Washington lies the inscription of 
John Philpot Curran's famous quote: ``Eternal vigilance is the price of 
liberty.'' The legislation before us establishes the first down payment 
on securing our borders. I want to congratulate Chairman Tauzin and the 
distinguished Ranking Member, John Dingell, for their vision on this 
project, as well as all the other subcommittee chairs, their ranking 
members and the committee staff for its hard work.
  As Chairman of the House Subcommittee on Environment and Hazardous 
Materials, which has jurisdiction over hazardous chemicals and drinking 
water, I am particularly pleased with many of the sections in this 
bill. Our committee has been researching and evaluating over the last 
couple of months to come up with a reasoned and responsible approach. 
We have worked hard to encourage improvement in places that needed it 
and avoided either slowing or punishing those who have taken pro-active 
steps to secure our public's health and its environment.
  For starters, Title II of this bill closes current reporting 
loopholes for those people either receiving or transporting select, 
dangerous toxic agents. Now, not only will there be an established 
screening process to keep suspected criminals or terrorists away from 
these chemicals, but all people who possess these chemicals must report 
that they have them to the Federal government.
  In addition, Title III of our legislation provides new procedures to 
assess and detect efforts to intentionally harm our food and its 
delivery system. The legislation calls for advance notice of food 
coming into the country, extra maintenance of shipping records, and 
grants new authorities and money to the Federal government to 
commission food inspectors to handle any manpower shortages.
  Finally, Title IV addresses the crucial issue of protecting our 
nation's drinking water. It encourages water systems to assess their 
vulnerabilities, come up with a response plan, and take any necessary 
actions to secure their facilities. Next, it calls for a review of 
current methods to diminish threats as well as for biomedical research 
on chemical, biological, and radiological contaminants. And on the 
issue of unfunded mandates, this title provides the funding to 
communities to make requirements become realities.
  Mr. Speaker, again, I thank you for this time to speak in favor of 
this bill and I urge all my colleagues to support it. As I mentioned at 
the beginning of my remarks, freedom is not free. We can take the step 
of learning from September 11 and prepare for the future. Or, we can 
hold our breath and ``wait for the other shoe to drop.'' I hope we will 
all decide to be vigilant.
  Ms. SLAUGHTER. Mr. Speaker, I rise today in strong support of the 
Public Health Security and Bioterrorism Response Act.
  Three months ago, our Nation was the victim of a vicious and 
unprincipled terrorist attack. Thousands of innocent Americans perished 
in New York, Virginia, and Pennsylvania. We owe it to the victims, 
survivors, and their families to ensure that this terrible tragedy 
cannot be repeated.
  The Public Health Security and Bioterrorism Response Act is an 
important step toward guaranteeing the safety and security of all our 
citizens. This bill will make major strides in protecting our food 
supply and our water supply. It will allow the government to track the 
movement of deadly biological agents and toxins, such an anthrax. And 
perhaps most importantly, it will significantly upgrade our public 
health infrastructure to allow for coordination, information sharing, 
and dissemination of crucial data.
  I would like to extend my personal gratitude to Commerce Committee 
Chairman Billy Tauzin and Ranking Member John Dingell for including in 
this package numerous provisions from by bill, H.R. 3106, the 
Protecting America's Children Against Terrorism Act. I was proud to 
sponsor this bill along with my colleague from New York, Senator 
Hillary Rodham Clinton. Significant portions of this legislation were 
also included in the Senate's bioterrorism package, S. 1756.
  The Public Health Security and Bioterrorism Response Act includes 
portions of H.R. 3106 addressing: The establishment of an advisory 
committee on children and terrorism; Training for health care personnel 
to meet the needs of children in the event of a public health 
emergency; Increased research on issues such as

[[Page H9217]]

the proper dosages of vaccines and antidotes for children; and The 
inclusion of pediatric supplies and equipment in the National 
Pharmaceutical Stockpile Program.
  These provisions are crucial to ensure that our nation is prepared to 
care for children in the event of any type of public health emergency. 
The events of September 11 revealed to us the gaps in our systems for 
dealing with such an emergency; it is our duty to address those needs 
before we are called upon to respond again.
  Mr. Speaker, I fully support the Public Health Security and 
Bioterrorism Response Act and urge my colleagues to do the same.
  Mr. UPTON. Mr. Speaker, I rise in strong support of the Public Health 
Security and Bioterrorism Response Act. Just as the horrendous 
terrorist attacks of September 11th brought home to Americans the cruel 
face of hate, fanaticism, and outright evil and the need to wage war on 
international terrorism, so the anthrax attacks have brought home to us 
our vulnerability to bioterrorism attacks on our homefront.
  What was perhaps an abstract concern has become very, very real. I 
have traveled home to my district every week since September 11th, and 
I have heard the real fear in mothers' and fathers' voices and in the 
questions children ask me when I visit with them in their schools. Will 
we be ready should our communities suffer anthrax or smallpox attacks? 
Will we have the vaccines and antibiotics we need? Will emergency 
response teams and emergency medical services be ready to swing quickly 
into action? Will our health professionals be trained to recognize 
symptoms and quickly communicate suspicious outbreaks?
  While home in Michigan, I have also met with emergency response teams 
at the local and state levels. While they are doing their best to 
prepare coordinated responses to worst-case scenarios, they need better 
tools--better weapons in their armories--to meet the threat of 
bioterrorist attacks.
  Enacting the comprehensive, bipartisan bill before us today will go a 
long way in giving my local communities, my state, and this nation the 
tools and infrastructure needed to assure individuals and families and 
communities across the nation that we will have the strongest possible 
defense against potential acts and the ability to respond quickly and 
effectively should an attack nevertheless succeed.
  Specifically, this bill will provide the funds necessary to 
substantially upgrade the Centers for Disease Control and Prevention's 
laboratories, facilities and communications capacities, as well as our 
state and local public health department's capabilities. It will create 
a national stockpile of vaccines, biologics, drugs, and medical devices 
to meet the health security needs of our people. The bill recognizes 
the enormous challenges that not only the CDC, but also the Food and 
Drug Administration must meet if we are to be prepared with sufficient 
vaccines and effective antibiotics. It provides the FDA with the 
authorities needed to meet those challenges without compromising public 
health. This bill will also slam shut some gaping loopholes in our 
regulation of the possession of chemical and biological agents that 
could be used to launch attacks. And it provides comprehensive 
protection for our drinking water and food supplies.
  I am proud, not only as a Member of Congress, but also as a husband 
and father and community leader to be an original cosponsor of the 
Public Health Security and Bioterrorism Response Act of 2001. With the 
passage and enactment of this bill, we can say ``YES'' when a parent, a 
student, or a local community leader asks us if we are prepared for 
bioterrorism.
  Ms. HARMAN. Mr. Speaker, I rise in strong support of the Public 
Health Security and Bioterrorism Response Act of 2001, and I commend 
Chairman Tauzin and Ranking Member Dingell for their leadership in 
fashioning this bipartisan measure. This important piece of legislation 
will take the first step toward ensuring that we will be able to 
prevent--and better respond to--any future bioterrorist attack.
  The National Commission on Terrorism, on which I served last year, 
concluded that it is not a matter of if a bioterrorist attack will 
occur, but only a question of when. We saw that expectation realized in 
October and November, when anthrax-laden letters caused the death of 
six Americans. And we will likely see it happen again.
  Substantial evidence exists that al Qaeda and rogue states like Iraq 
have attempted to acquire biological agents, and they have certainly 
proven their ability to inflict mass death on the United States. the 
treat of bioterrorism is real, and our nation must be prepared to 
respond to any eventuality.
  Our Government's response to the bioterrorist attacks of October was 
deeply flawed. We have talented people and good plans, but we have been 
lacking the resources and coordination to make our response effective. 
We must act now to improve our terrorism response, before another 
tragedy occurs.
  This legislation improves the coordination and capacity of 
bioterrorism response, the security of biological agents, and the 
safety of our food and water supplies. It makes a substantial 
investment in programs that fund communications systems, laboratory 
improvements, and training programs across the nation.
  Most important, the bill directs this investment to the state and 
local governments that need it most. All terrorism response is local, 
but in the past far too much of our counterterrorism funding has 
remained at the federal level. This bill will begin to correct this 
deficiency.
  I am particularly glad that this bill includes funds to speed up the 
renovation of CDC's buildings and facilities. I have visited to the 
Centers for Disease Control and Prevention in Atlanta and seen talented 
people working in shabby conditions. This legislation will invest $300 
million in each of the next two years to improve the security of CDC 
facilities and construct much-needed research facilities. Improving our 
bioterrorism response must begin with the basics--and that means 
investing in critical infrastructure and facilities.
  I am proud to cosponsor this legislation, and encourage all of my 
colleagues to support these needed measures.
  Mr. TAUZIN. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. Terry). The question is on the motion 
offered by the gentleman from Louisiana (Mr. Tauzin) that the House 
suspend the rules and pass the bill, H.R. 3448.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of 
those present have voted in the affirmative.
  Mr. TAUZIN. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the 
Chair's prior announcement, further proceedings on this motion will be 
postponed.

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