[Congressional Record Volume 147, Number 152 (Tuesday, November 6, 2001)]
[Senate]
[Pages S11488-S11493]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. HUTCHINSON (for himself and Mr. Gregg):

[[Page S11489]]

  S. 1635. A bill to ensure the prompt research, development, 
manufacture, and distribution of new life-saving drugs, biologics, and 
medical devices that prevent or mitigate the consequences of a chemical 
or biological bioterrorist attack, and for other purposes; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. HUTCHINSON. Mr. President, I ask unanimous consent that the text 
of the bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1635

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Pathogen Research, Emergency 
     Preparedness and Response Efforts Act of 2001'' or the 
     ``PREPARE Act''.

     SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

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

``TITLE XXVIII--DEVELOPING NEW COUNTERMEASURES AND PROTECTING EXISTING 
                  COUNTERMEASURES AGAINST BIOTERRORISM

     ``SEC. 2801. DEVELOPMENT OF DRUGS, BIOLOGICAL PRODUCTS, AND 
                   MEDICAL DEVICES TO COMBAT BIOTERRORISM.

       ``(a) Identification of Chemical or Biological Agents or 
     Toxins.--
       ``(1) In general.--The Secretary, in consultation with the 
     Secretary of Defense and the Attorney General, shall identify 
     chemical or biological agents or toxins that may be 
     identified, prevented, or treated through--
       ``(A) the development of new covered products;
       ``(B) the development of new uses, including pediatric 
     uses, for approved covered products; or
       ``(C) the manufacture or distribution of covered products 
     that would otherwise not be manufactured or distributed in 
     sufficient quantities.
       ``(2) Publication and availability.--Not later than 180 
     days after the date of enactment of this title, and annually 
     thereafter, the Secretary shall publish in the Federal 
     Register, or otherwise make available to manufacturers or 
     potential manufacturers of covered products, a list of the 
     chemical or biological agents and toxins identified under 
     paragraph (1) for which the Secretary desires to encourage 
     the development of, or new uses for, covered products or the 
     manufacture or distribution of such covered products.
       ``(b) Consultation.--In carrying out this section, the 
     Secretary shall consult with experts in the pharmaceutical, 
     biotechnology, and medical device industries, academic 
     medical centers, and research institutions, including those 
     with pediatric expertise.
       ``(c) Limited Antitrust Exemption.--
       ``(1) Countermeasures development meetings.--
       ``(A) Scheduling countermeasures development meetings.--The 
     antitrust laws shall not apply to meetings or consultations 
     conducted by the Secretary with parties involved in the 
     development of countermeasures for the purpose of the 
     development, manufacture, distribution, and sale of 
     countermeasures that are prioritized under section 2841(c), 
     consistent with the purposes of this title. The Secretary 
     shall give notice to the Assistant Attorney General of 
     Antitrust of meetings scheduled pursuant to this subsection.
       ``(B) Meeting conditions.--Any meeting under subparagraph 
     (A)--
       ``(i) shall be chaired by the Secretary;
       ``(ii) shall be open to parties involved in the development 
     of countermeasures, as determined by the Secretary;
       ``(iii) shall be open to the Attorney General and the 
     Federal Trade Commission;
       ``(iv) shall be limited to discussions involving the 
     development, manufacture, distribution, or sale of 
     countermeasures that are prioritized under section 2841(c); 
     and
       ``(v) shall be conducted in such manner as to ensure that 
     national security, confidential, and proprietary information 
     is not disclosed outside the meeting.
       ``(C) Minutes.--The Secretary shall ensure that minutes of 
     the meeting are maintained.
       ``(2) Applying for limited exemption.--
       ``(A) Filing procedures.--As a result of meetings in 
     paragraph (1), the Secretary and participating parties may 
     file a written request with the Attorney General for a 
     limited exemption from the antitrust laws to allow 
     appropriate parties to enter into agreements or engage in 
     conduct relating to the development, manufacture, 
     distribution, or sale of countermeasures prioritized under 
     section 2841(c). Any such request shall set forth the 
     intended purpose of the agreement, including an explanation 
     as to why a cooperative effort among potential competitors is 
     necessary to achieve the objective of the agreement. The 
     request shall state with specificity the substance of the 
     agreement, the methods that will be utilized to achieve the 
     objectives of the agreement, and other relevant information 
     relating to the development and production of countermeasures 
     that are prioritized under section 2841(c).
       ``(B) Grant of exemption.--The Attorney General, in 
     consultation with the Chairman of the Federal Trade 
     Commission shall grant, deny, grant in part and deny in part, 
     or propose modifications to any request made pursuant to 
     subparagraph (A) for exemption from the antitrust laws. In 
     making the determination to grant, deny, grant in part and 
     deny in part, or propose modifications to any such request, 
     the Attorney General shall consider among other things: 
     whether such agreement would promote the purposes of this 
     Act, whether the exemption from the antitrust laws would 
     promote the public interest, and the competitive impact to 
     areas not directly related to the development and production 
     of countermeasures prioritized under section 2841(c). The 
     Attorney General shall make a determination on a request 
     filed pursuant to subparagraph (A) within 60 days.
       ``(C) Sunset.--The authority of the Attorney General to 
     grant a limited antitrust exemption under this section 
     expires at the end of the 2-year period beginning on the date 
     of enactment of the Pathogen Research, Emergency Preparedness 
     and Response Efforts Act of 2001.

     ``SEC. 2802. CONTRACTS FOR DEVELOPMENT OF COVERED PRODUCTS.

       ``(a) Authority.--The Secretary may enter into contracts, 
     cooperative research and development agreements pursuant to 
     section 11(a) of the Stevenson-Wydler Technology Innovation 
     Act of 1980 (15 U.S.C. 3710(a)), material transfer 
     agreements, or other agreements, or agree to the amendment or 
     modification of existing or future contracts or agreements, 
     for the development, manufacture or distribution of covered 
     products for uses or new uses identified by the Secretary 
     pursuant to section 2801(b). A contract or agreement entered 
     into, or amended or modified, under this subsection may 
     address 1 or more aspects of the development, manufacture, or 
     distribution of 1 or more uses of 1 or more covered products. 
     Such contracts or agreements may set forth guaranteed minimum 
     quantities of products and negotiated unit prices.
       ``(b) Timing of Contract.--Notwithstanding any other 
     provision of law, the Secretary may enter into a contract or 
     agreement under subsection (a) even prior to the development, 
     approval, or clearance of the covered product that is the 
     subject of the contract or agreement. Such contract or 
     agreement may provide for the termination of the contract or 
     agreement for the convenience of the Federal Government if 
     the contractor fails to develop the covered product involved.
       ``(c) Payments.--Payments under a contract or agreement 
     under subsection (a) may be made from--
       ``(1) funds obligated for the performance of the contract 
     or agreement involved;
       ``(2) funds available for the development, manufacture, 
     distribution, or purchase of covered products for uses 
     referred to in section 2801(b); or
       ``(3) any other funds available to the Secretary.
       ``(d) Contracts.--In administering the provisions of this 
     section, the Secretary may enter into contracts in advance of 
     appropriations and incur obligations without regard to 
     provisions of law relating to contracts, including sections 
     1341, 1342, 1349, 1350, and 1351, and subchapter II of 
     chapter 15, of title 31, United States Code.

     ``SEC. 2803. INDEMNIFICATION.

       ``The Secretary shall, in any contract or agreement for the 
     manufacture, development, distribution, or the purchase of a 
     covered product intended for a use identified by the 
     Secretary pursuant to section 2801(b), indemnify and hold 
     harmless the contractor consistent with the following 
     principles:
       ``(1) Uses covered.--Indemnification only extends to uses 
     of the covered product pursuant to a contract entered into by 
     the Secretary under section 2802.
       ``(2) Entities covered.--The Secretary may indemnify 
     contractors, subcontractors, distributors, persons who 
     administer covered products, or other parties as determined 
     appropriate by the Secretary pursuant to contracts entered 
     into under section 2802.
       ``(3) Limits.--No indemnification shall be provided for 
     intentional torts by the contractor or torts by the 
     contractor involving gross negligence or recklessness.

     ``SEC. 2804. HIGH QUALITY PRODUCTION.

       ``The Secretary may, with the agreement of the manufacturer 
     of a drug, biological product, or medical device that is 
     approved, licensed, or cleared (or awaiting approval, 
     licensure or clearance) under section 505, 510, 513, or 515 
     of the Federal Food, Drug, and Cosmetic Act, or section 351 
     of this Act, and is a covered product, provide intensive 
     assistance, including on-site assistance, when necessary, in 
     order to facilitate prompt compliance with good manufacturing 
     practice regulations under sections 210, 211, 225, 226, 600, 
     601, 606, or 820 of title 21, Code of Federal Regulations, in 
     the manufacturing, processing, packing, or holding of the 
     drug, biological product, or medical device.

     ``SEC. 2805. SECURITY FOR RESEARCH AND PRODUCTION.

       ``(a) In General.--The Secretary, in consultation with the 
     Attorney General and the Secretary of Defense, may award 
     grants, contracts, or enter into cooperative agreements, and 
     provide technical or nonmonetary assistance, to provide 
     security to facilities that conduct research, development, 
     production, distribution, and storage of covered products.
       ``(b) Best Practices.--The Secretary shall develop 
     guidelines and best practices to enable entities eligible for 
     funding under this section to secure their facilities against 
     potential bioterrorist attack.

[[Page S11490]]

     ``SEC. 2806. MOBILITY OF STOCKPILE.

       ``(a) Special Events.--In managing the National 
     Pharmaceutical Stockpile, the Secretary, in consultation with 
     State and local government officials, shall take into 
     consideration the timing and location of special events, 
     including designated national security events.
       ``(b) Location of Certain Stocks.--In carrying out 
     subsection (a), the Secretary shall ensure that medical 
     supplies from the National Pharmaceutical Stockpile are 
     located in appropriate proximity to the site of the special 
     event.

     ``SEC. 2807. DEFINITIONS.

       ``In this title:
       ``(1) Antitrust laws.--The term `antitrust laws'--
       ``(A) has the meaning given such term in subsection (a) of 
     the first section of the Clayton Act (15 U.S.C. 12(a)), 
     except that such term includes section 5 of the Federal Trade 
     Commission Act (15 U.S.C. 45) to the extent such section 5 
     applies to unfair methods of competition; and
       ``(B) includes any State law similar to the laws referred 
     to in subparagraph (A).
       ``(2) Biological agents or toxins.--The term `biological 
     agents or toxins' has the meaning given in section 178 of 
     title 18, United States Code.
       ``(3) Covered products.--The term `covered products' 
     includes drugs, biological products including vaccines, and 
     medical devices including in vitro diagnostics, that may be 
     developed or produced to identify, prevent, or treat disease 
     or harm in humans, including children and other vulnerable 
     populations, resulting from an attack or threatened attack 
     using chemical or biological agents or toxins.
       ``(4) Development.--The term `development' includes the 
     identification of suitable compounds or biological materials, 
     the conduct of preclinical and clinical studies, the 
     preparation of an application for marketing approval or 
     clearance, the conduct of post-market or post-approval 
     studies, and any other actions related to preparation of a 
     covered product.''.

     SEC. 2. EXPEDITING FDA REVIEW AND APPROVAL.

       (a) Amendment.--Section 506 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 356) is amended by adding at the end 
     the following:
       ``(e) Chemical or biological Agents or Toxins.--
       ``(1) In general.--The Secretary may designate an 
     unapproved covered product identified pursuant to section 
     2801(b) of the Public Health Service Act as a fast-track 
     product pursuant to this section. Such a designation may be 
     made prior to the submission of--
       ``(A) a request for designation by the sponsor; or
       ``(B) an application for the investigation of the drug 
     under section 505(i) or section 351(a)(3) of the Public 
     Health Service Act.''.
       ``(2) Use of animal trials.--An application for a drug for 
     which approval is sought on the basis of evidence of 
     effectiveness that is derived from animal studies under the 
     last sentence of section 505(d) or section 351(a)(1) of the 
     Public Health Service Act may be designated as a fast track 
     product for purposes of this section.''.
       (b) Review.--The Secretary shall grant priority review to a 
     submission for a covered product, unless the sponsor has 
     filed an application for review of the product under section 
     506.

     SEC. 3. USE OF ANIMAL TRIALS IN THE APPROVAL OF COVERED 
                   PRODUCTS.

       (a) New Drugs.--Section 505(d) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(d)) is amended by adding at 
     the end the following: ``In the case of drugs for use against 
     a potentially lethal or permanently disabling toxic chemical 
     or biological agent or toxin, when adequate and well-
     controlled studies in humans cannot ethically be conducted 
     because the studies would involve administering such an agent 
     or toxin to healthy human volunteers without a proven 
     treatment, and when adequate field trials assessing the use 
     of the drug (in situations such as after accidental or 
     hostile exposure to the substance) have not been feasible, 
     the Secretary may grant approval, including approval for 
     pediatric populations, based on evidence derived from 
     appropriate studies in animals or other information. The 
     Secretary may use existing authority under section 506 or 
     other relevant provisions to order post-marketing approval 
     studies. Drugs approved solely under the authority of the 
     preceding two sentences shall be for purposes of identifying, 
     treating, or preventing infection, disease, injury, or other 
     health condition or consequence resulting from a disabling 
     toxic chemical, biological, radiological, nuclear attack, 
     potential attack, or other significant disease emergency as 
     the Secretary may determine appropriate.''.
       (b) New Biological Products.--Section 351 of the Public 
     Health Service Act (42 U.S.C. 262) is amended by adding at 
     the end the following:
       ``(k) Approval of Certain Products Based on Animal 
     Trials.--
       ``(1) In general.--In the case of biological products for 
     use against a potentially lethal or permanently disabling 
     toxic chemical, biological, radiological, nuclear, or other 
     agent or toxins, when adequate and well-controlled studies in 
     humans cannot ethically be conducted because the studies 
     would involve administering such an agent or toxin to human 
     volunteers without a proven treatment, and when adequate 
     field trials assessing the use of the biological product (in 
     situations such as after accidental or hostile exposure to 
     the substance) have not been feasible, the Secretary may 
     grant approval, including approval for pediatric populations, 
     based on evidence derived from appropriate studies in animals 
     or other information.
       ``(2) Post-approval studies.--With respect to products 
     described in paragraph (1), the Secretary may use existing 
     authority under section 506 of the Federal Food, Drug, and 
     Cosmetic Act to order post-marketing approval studies.
       ``(3) Limitations.--Biological products approved solely 
     under the authority of this subsection shall be for purposes 
     of identifying, treating, or preventing infection, disease, 
     injury, or other health condition or consequence resulting 
     from a potentially disabling toxic chemical, biological, 
     radiological, nuclear attack, potential attack, or other 
     significant disease emergency as the Secretary may determine 
     appropriate.''.
       (c) Final Rule.--Not later than 60 days after the date of 
     enactment of Pathogen Research, Emergency Preparedness and 
     Response Efforts Act of 2001, the Secretary shall finalize 
     the proposed rule published on October 5, 1999 regarding the 
     use of animal trials in the approval of products.

     SEC. 4. CHEMICAL OR BIOLOGICAL AGENTS AND TOXINS.

       (a) In General.--Chapter V of the Federal Food, Drug and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
     the end the following:

           ``PART E--CHEMICAL OR BIOLOGICAL AGENTS AND TOXINS

     ``SEC. 570. AUTHORITY TO RESTRICT TRANSPORTATION AND USE.

       ``(a) In General.--The Secretary shall undertake a program 
     that, through inspections and other containment procedures, 
     will prohibit the unauthorized shipment or transportation in 
     interstate or foreign commerce, the possession or other use 
     in or affecting commerce, or assistance to another person in 
     such transportation, shipment, or other use by any person of 
     chemical or biological agents or toxins or the receipt of 
     such chemical or biological agents or toxins so shipped or 
     transported.
       ``(b) Definitions.--In this section:
       ``(1) Chemical or biological agents and toxins.--The term 
     `chemical or biological agents and toxins' has the meaning 
     given such term in section 2801(a) of the Public Health 
     Service Act refers to a biological agent or toxin listed as a 
     `select agent' in section 72.6(j) of title 42, Code of 
     Federal Regulations, which is not exempt under section 
     72.6(h) or appendix A of such title and which does not 
     include any such biological agent or toxin that is in its 
     naturally-occurring environment and that has not been 
     cultivated, collected, or otherwise extracted from its 
     natural source.
       ``(2) Person.--The term `person' includes an alien (other 
     than an alien admitted for permanent residence) who is a 
     national of a country as to which the Secretary of State has 
     made a determination (that is in effect) that such country 
     has repeatedly provided support for acts of international 
     terrorism.''.
       (b) Enforcement.--Section 301 of the Federal Food, Drug and 
     Cosmetic Act (21 U.S.C. 331) is amended by adding at the end 
     the following:
       ``(aa) The shipment, transportation, possession or other 
     use, assistance with respect to, or receipt of a biological 
     agent or toxin in violation of section 570.''.

     SEC. 5. REGULATION OF CHEMICAL OR BIOLOGICAL AGENTS AND 
                   TOXINS POSING POTENTIAL NATIONAL SECURITY 
                   THREAT.

       (a) Redesignation and Clarification of Chemical or 
     Biological Agents; Regulatory Provisions of Antiterrorism and 
     Effective Death Penalty Act of 1996.--
       (1) In general.--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 CHEMICAL OR BIOLOGICAL 
                   AGENTS AND TOXINS.

       ``(a) Regulatory Control of Chemical or Biological Agents 
     and Toxins.--
       ``(1) List of chemical or biological agents and toxins.--
     The Secretary shall, through regulations promulgated under 
     subsection (c), 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.
       ``(2) Criteria.--In determining whether to include an agent 
     or toxin on the list under subsection (a), the Secretary 
     shall--
       ``(A) consider--
       ``(i) the effect on human health of exposure to the agent 
     or toxin;
       ``(ii) the degree of contagiousness of the agent or toxin 
     and the methods by which the agent or toxin is transferred to 
     humans;
       ``(iii) the availability and effectiveness of 
     pharmacotherapies and immunizations to treat or prevent any 
     illness resulting from infection by the agent or toxin; and
       ``(iv) any other criteria that the Secretary considers 
     appropriate; and
       ``(B) consult with scientific experts representing 
     appropriate professional groups.
       ``(b) Regulation of Transfers of Listed Chemical or 
     Biological Agents and Toxins.--The Secretary shall, through 
     regulations promulgated under subsection (c), provide for--
       ``(1) the establishment and enforcement of safety 
     procedures for the transfer of chemical or biological agents 
     and toxins listed

[[Page S11491]]

     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 
     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 chemical or biological 
     agents and toxins for research, education and other 
     legitimate purposes.
       ``(c) Regulations.--The Secretary shall promulgate 
     regulations to carry out this section.
       ``(d) Definitions.--For purposes of this section and 
     section 351B, the term `biological agent and toxin' shall 
     have the meaning given such term in section 2801(a).''.
       (2) 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) Effective date.--The amendments made by this subsection 
     shall take effect as if incorporated in the Antiterrorism and 
     Effective Death Penalty Act of 1996.
       (b) Regulation of Chemical or Biological Agents and Toxins 
     Posing Potential National Security Threat.--
       (1) In general.--Part F of title III of the Public Health 
     Service Act (42 U.S.C. 262 et seq.), as amended by subsection 
     (a)(1), is further amended by inserting after section 351A, 
     the following:

     ``SEC. 351B. REGULATION OF CHEMICAL OR BIOLOGICAL AGENTS AND 
                   TOXINS POSING POTENTIAL NATIONAL SECURITY 
                   THREAT.

       ``(a) In General.--
       ``(1) List of chemical or biological agents and toxins 
     posing national security threat.--The Secretary shall, 
     through regulations promulgated under subsection (d), 
     establish and maintain a list of those chemical or biological 
     agents and toxins listed pursuant to section 351A(a)(1) that 
     the Secretary determines to be a potential national security 
     threat.
       ``(2) Criteria.--In determining whether to include an agent 
     or toxin on the list under subsection (a), the Secretary 
     shall--
       ``(A) consider the criteria specified in section 
     351A(a)(2)(A)(i), and any other criteria that the Secretary 
     considers appropriate; and
       ``(B) consult with scientific, intelligence, and military 
     experts representing appropriate professional groups.
       ``(b) Regulation of Transfers of Listed Chemical or 
     Biological Agents and Toxins.--The Secretary shall, through 
     regulations promulgated under subsection (d), provide for the 
     establishment and enforcement of standards and procedures 
     governing the possession, use, and transfer of chemical or 
     biological agents and toxins listed pursuant to subsection 
     (a)(1) that are designed to protect public safety and 
     national security, including safeguards to prevent access to 
     such agents and toxins for use in domestic or international 
     terrorism or for any other criminal purpose.
       ``(c) Civil Money Penalties.--A violation of a requirement 
     imposed by a regulation promulgated under this section shall 
     be subject, in addition to any other applicable civil or 
     criminal sanctions, to a civil money penalty in an amount not 
     to exceed $250,000.
       ``(d) Regulations.--The Secretary shall promulgate 
     regulations to carry out this section.
       ``(e) Freedom of information act exemption.--Any 
     information provided to the Secretary pursuant to regulations 
     issued under subsection (d) or under section 351A(c) shall 
     not be disclosed under section 552 of title 5, United States 
     Code.''.
       (2) Effective date.--The amendment made by this subsection 
     shall take effect as if incorporated in the Antiterrorism and 
     Effective Death Penalty Act of 1996.

     SEC. 6. ADMINISTRATION.

       In administering the provisions of this Act, the Secretary 
     of Health and Human Services shall--
       (1) continue to recognize and honor rights relating to 
     patents, data, and copyrights; and
       (2) comply with all applicable provisions of the 
     regulations relating to Federal acquisition, the Federal 
     Trade Secrets Act, and all other laws protecting confidential 
     commercial information, trade secrets, and intellectual 
     property rights, and patent and non-patent market exclusivity 
     rights.

     SEC. 7. COORDINATION OF EFFORTS TO PROTECT AGAINST 
                   BIOTERRORISM.

       The Secretary of Health and Human Services shall coordinate 
     with the Secretary of Defense in the planning, design, and 
     construction of a Department of Defense government-owned, 
     contractor-operated vaccine production facility on a military 
     installation, as appropriate.

     SEC. 8. ENHANCEMENT OF PENALTIES FOR ANIMAL AND PLANT 
                   ENTERPRISE TERRORISM.

       Section 43 of title 18, United States Code, is amended--
       (1) in subsection (a), by striking ``one year'' and 
     inserting ``5 years'';
       (2) in subsection (b)--
       (A) by redesignating paragraph (2) as paragraph (3);
       (B) by inserting after paragraph (1) the following:
       ``(2)  Explosives or arson.--Whoever in the course of a 
     violation of subsection (a) maliciously damages or destroys, 
     or attempts to damage or destroy, by means of fire or an 
     explosive, any building, vehicle, or other real or personal 
     property used by the animal or plant enterprise shall be 
     imprisoned for not less than 5 years and not more than 20 
     years, fined under this title, or both.''; and
       (C) in paragraph (3), as so redesignated, by striking 
     ``under this title and'' and all that follows through the 
     period and inserting ``under this title, imprisoned for life 
     or for any term of years.''; and
       (3) in subsection (c)--
       (A) by striking ``and'' at the end of paragraph (1);
       (B) by striking the period at the end of paragraph (2) and 
     inserting ``; and''; and
       (C) by adding at the end the following:
       ``(3) for any other economic damage resulting from the 
     violation of this section.''.
                                 ______
                                 
      By Mr. BAUCUS:
  S. 1636. A bill to authorize the negotiation of a Free Trade 
Agreement with Taiwan, and to provide for expedited congressional 
consideration of such an agreement; to the Committee on Finance.
  Mr. BAUCUS. Mr. President. I rise today to introduce the United 
States--Taiwan Free Trade Agreement Act of 2001. This bill authorizes 
the President to begin negotiations with Taiwan on a Free Trade 
Agreement, FTA, and provides for fast track consideration of a 
completed agreement by the Congress. Like the U.S.-Jordan Free Trade 
Agreement that was passed earlier in the session, this bill emphasizes 
the importance of promoting sustainable development and maintaining 
strong labor laws.
  Over the past two decades, Taiwan has emerged as an important U.S. 
ally in the Asia-Pacific region. Together, we have worked to maintain 
peace and promote development throughout the region. As part of this 
process, the United States has committed itself to defending Taiwan 
from aggressive attacks, and provides millions of dollars annually in 
military aid to the island.
  Taiwan has emerged as a vocal supporter of U.S. policy throughout 
Asia and the world. After the September 11 terrorist attacks, Taiwan 
was one of the first nations to express condolences and offer whatever 
aid we might need.
  The ties between the United States and Taiwan extend beyond political 
ones, however.
  Taiwan is the United States' eighth largest trading partner, despite 
not yet being a member of the World Trade Organization. In 2000, the 
U.S. exported more than $22 billion worth of goods and services to 
Taiwan, more than we exported to either China or Hong Kong.
  The trade relationship between the United States and Taiwan has 
blossomed despite the fact that Taiwan is largely excluded from the 
international forums that help promote economic and political 
liberalization. For example, Taiwan is not a member of the United 
Nations.
  This international isolation will start to end in 2002, when Taiwan 
is scheduled to become a member of the World Trade Organization, WTO. 
As part of the membership process, Taiwan made a number of trade 
concessions to further liberalize its trade regime; the U.S. will 
benefit from the lowered tariffs and declining market barriers that 
were part of these concessions.
  There are opportunities in the Taiwanese market that we must look to 
seize. For example, U.S. agricultural producers have been particularly 
under-represented in the list of exports to the region.
  A U.S.-Taiwan FTA could eliminate the last barriers to U.S. exports 
to Taiwan. Exporters, particularly agricultural exporters, would 
finally have unfettered access to a market of more than 22 million 
people. Moreover, importers would benefit from reduced tariffs and 
easier customs regulations.
  The economic rationale for a U.S.-Taiwan FTA is indisputable. But the 
United States has always exported more than just its goods and 
services. This Nation's support of freedom and democracy throughout the 
world has been its most important trade policy for more than two 
hundred years.
  Taiwan shares these values and deserves the continued support, both 
political and economic, of the United States. Over the past fifty 
years, Taiwan has evolved from single-party rule to a nation of free 
and open elections, where the transfer of power takes place

[[Page S11492]]

smoothly and peacefully. Today, it is a vibrant democracy that is 
continuing to progress towards open markets and liberalized trade. 
Supporting this process with an FTA not only encourages Taiwan to 
continue its economic reforms, it also serves as an explicit example of 
the very real benefits of opening markets for those countries that are 
just beginning to participate in the global trading system.
  A free trade agreement with Taiwan is a concrete step that the United 
States can take towards supporting an ally that shares our values. The 
fact that such an agreement also promises concrete economic benefits to 
American farmers and manufacturers makes this process even more 
essential.
  I urge my colleagues to join me in supporting the United States-
Taiwan Free Trade Agreement Act of 2001.
                                 ______
                                 
      By Mr. BOND:
  S. 1638. A bill to authorize the Secretary of the Interior to study 
the suitability and feasibility of designating the French Colonial 
Heritage Area in the State of Missouri as a unit of the National Park 
System, and for other purposes; to the Committee on Energy and Natural 
Resources.
  Mr. BOND. Mr President, I rise today to introduce legislation 
recognizing the historical significance of downtown Sainte Genevieve, 
MO. Sainte Genevieve was one of the first European settlements west of 
the Mississippi River, and still contains many structures and artifacts 
that have survived from its rich early history. Establishing this area 
as a unit of the National Park System will provide an unparalleled 
opportunity for Americans to be educated about our Nation's colonial 
past.
  Sainte Genevieve was founded by French settlers in the mid Eighteenth 
Century. These early pioneers traveled south from French Canada, and 
built the rare French Colonial style structures that remain in place to 
this day. Today, the area contains an invaluable wealth of Native 
American and French Colonial sites, artifacts, and architecture. 
Perhaps most impressively, downtown Sainte Genevieve contains three of 
only five poteaux-en-terre (posts in the ground) vertical log French 
homes remaining in North America, dating from the 1790's.
  In addition to the historic downtown district, the area adjacent to 
Sainte Genevieve is rich in historic sites. The ``Grand Champ'' common 
field of the French colonists still retains its original field land 
pattern. The area's saline salt springs were an important industry 
source for Native American and European settlers. And nearby ceremonial 
mounds are evidence of a prehistoric Native American village.
  This area is a truly valuable asset to the State of Missouri, and I 
feel that it is only fair to share it with the entire nation by 
establishing the French Colonial Heritage Area as a unit of the 
National Park System. My legislation would take the first step toward 
such an establishment by directing the National Park Service to conduct 
a study of the historic features of Sainte Genevieve. After a thorough 
study, I am confident that the National Park Service will determine 
that Sainte Genevieve is the best tool with which to tell the important 
and fascinating story of the French in the New World.
                                 ______
                                 
      By Mr. SESSIONS (for himself and Mr. Nickles):
  S. 1641. A bill to impose additional requirements to ensure greater 
use of the advance payment of the earned income credit and to extend 
such advanced payment to all taxpayers eligible for the credit; to the 
Committee on Finance.
  Mr. SESSIONS. Mr. President, I take this opportunity to discuss 
legislation I have offered that would be good public policy for the 
country and a terrific stimulus for the economy beginning in January. 
Let me explain what this is about.
  We have in this country a policy of helping the working poor called 
the earned income tax credit. That was passed in 1975. It was designed 
to help lower income people working on an hourly wage have a higher 
income to take care of their families. It is shaded in fact pretty 
heavily in favor of low-income people who have children.
  It has worked well on the whole. There have been a lot of people who 
have criticized it. They have called it welfare. In a way, it is a 
benefit given. But it is a benefit given in exchange for work, when a 
person works. It is a benefit from the Federal Government called the 
earned income tax credit. It is a tax credit. If you work, you earn it. 
It has in general been a good way to help the working poor, as we call 
them today. Since 1975, we have done that.
  The way the person receives the money, however, is detached from 
their work. The way a person receives their earned income tax credit is 
to file their tax return in February, March, April and get a tax return 
the next year after working all year. For example, for the year 2001, a 
low-income worker with two or more children could claim $4,008 in 
earned income tax credit, a worker with one child could receive up to 
$2,428, and a worker with no children could receive $364. The average 
earned income tax credit for a beneficiary with a qualifying child, one 
child, in 1999, was $1,941. That is about $150 a month, almost $1 an 
hour when figured on 160 hours for a month. It is a significant benefit 
from the Federal Government.
  From a public policy point of view, it has been less effective in 
achieving the goal we want it to achieve, which is to encourage work, 
because it is received at the end of the year, really the next year; 
and it is disconnected to the work the person has undertaken.
  We want to encourage people to work. We want work to be more 
rewarding. We want a person making $6 an hour making $7 an hour, just 
like that. Let's have them make $8 an hour if they were making $7. This 
could be done if we could in fact have this earned income tax credit 
paid at the time the person works, as part of their paycheck.
  In fact, this idea had been discussed earlier, a number of years ago. 
We passed a bill in this Congress that would allow people to choose 
this and, oddly, not many people have. However, most people don't fully 
understand it. Others are afraid they might end up having a tax 
liability next year and didn't choose it. I don't think businesses have 
encouraged people to take it as much as they should and, as a result, 
only 5 percent of the people who are eligible and choose this earned 
income tax credit have it paid to them in advance when they work. So I 
think we have a problem there. We can strengthen our economy and we can 
strengthen the reward for a person going to work if we tie this credit 
to the work they do, to their paycheck.
  In addition, I have discovered that the earned income tax credit is 
worth, for America, $31 billion a year. That is a lot of money by any 
standard. As we are looking at this time how to create an infusion of 
cash into our economy in a way that would strengthen this economy to 
make it more healthy, more vibrant, to get people purchasing again, to 
put dollars in the hands of consumers, I can think of no better way 
with the least possible cost to the Treasury than to have this money 
that would be entitled to come in the next fiscal year actually start 
coming in January on a person's paycheck. I think that would be a 
tremendous way to pour additional money into the economy without having 
any impact on the Treasury, except the loss of interest on the money 
the Federal Government would be sitting on. This would not hurt poor 
people in any way. It would not withhold or delay them receiving any 
money. But in fact it would advance their receipt of the money. So they 
would be receiving in February, March, April, May, when their tax 
refund comes due, their refund under the earned income tax credit for 
this year's work, but they would have already begun on January 1 of 
this year to receive on their paycheck the money for next year. So it 
would advance that payment and would provide a real stimulus to the 
economy because low-income people are going to be the ones who are most 
likely to spend it.
  Remember, it would impact their paychecks significantly in that there 
is no withholding from this earned income tax credit. They will have 
already paid their insurance, retirement benefits, Social Security, 
FICA, and withholding taxes. All of that would have already been paid. 
Whatever they get in addition would be money they could put into their 
pockets. So it would achieve the goal of the earned income tax credit 
to enhance and make work more valuable and, at the same

[[Page S11493]]

time, would provide a tremendous stimulus to our economy. I am excited 
about this possibility, and I know Senator Reed, who is in the chair, 
and I have discussed this. He was at least intrigued by this idea.
  I was pleased today that Senator Nickles, who has been a critic of 
the earned income tax credit, one who has studied it carefully and has 
observed some of its problems, believes it is a good reform, and he is 
supporting and has signed onto this bill as an original cosponsor.
  So we have an opportunity to do something good for the economy, to do 
something good for poor people, to in effect have the businesses that 
now have to provide the option to their employees to go on and provide 
this money, which is reimbursed by the Federal Government immediately--
it doesn't cost them anything--and their workers would receive 50 or 60 
cents an hour pay raise as a result of this payment. I think it is 
something they ought to be excited about doing. I think it would 
enhance their workers benefits from working and make them better 
employees.

  So it is time for us to do it now. I have been concerned about the 
issue. I have studied it for a number of years. I had some independent 
research done on it several years ago, and I have been thinking and 
looking for an opportunity to present it in the form of legislation. At 
this time, when we need a financial stimulus, I can't think of a better 
time. So I am asking the Finance Committee, and I have talked with the 
Director of the OMB, Mitch Daniels, the Secretary of the Treasury, Mr. 
O'Neill, and his top staff person. They are all intrigued by this and 
believe it has merit.
  I think it is time for us to consider that this be a part of our 
stimulus package. It has little long-term impact on the Federal 
Treasury, but it would provide a tremendous infusion of cash into the 
economy just at the time we need people to go to the store and buy 
things, generating demand out there that would allow factories to 
produce more products. It would be giving additional wages to people 
who may be getting less overtime now than they were a year ago--maybe 
not even getting 40 hours a week now as they were last year. Those 
people would receive higher wages for each hour they do work.
  I talked to a businessperson today, and they said they were on 4-day 
workweeks with their employees. They hated to do it, but there wasn't 
demand for their products sufficient to keep them fully engaged. Rather 
than lay people off, they put everybody on a 4-day workweek. So a lot 
of people are losing hours, and this would help keep them from losing 
income. I think it is good for the low-income workers in America. I 
think it is good for the economy, and I think it is good public policy 
for America.
  Mr. President, we have talked with members of the Finance Committee 
and with the administration. I hope they will seize this opportunity to 
do something that, to me, has a win-win-win all over it, with no 
negatives. It is the right thing to do. Some say, well, business people 
may not want to handle the paperwork on this. Businesspeople print 
their checks out by computers, and it is not difficult for them. The 
money is paid to them. I talked to one gentlemen who hires employees--
quite a number of low-income workers. He said he though it was a 
wonderful idea. It would be great for his workers, and it would be no 
problem at all for them to make that a part of their payroll check 
plan. It is just a matter of getting the person who processes that to 
factor it in, and it works rather easily.
  Again, I believe it is a good idea, and I have submitted it to the 
Senate. I will be talking with the leadership and urging its passage. 
It is the right thing to do, and I think we ought to do it. The time is 
long past that we make this earned income tax credit really do what it 
is supposed to do, which is encourage work. It is to encourage people 
to work and, at the same time, when we do it by advancing it this year, 
we will provide a stimulus to the economy in a very significant way. We 
estimate that out of $31 billion in earned income tax credit, we would 
be advancing at least $15 billion next year, and that would be a 
healthy stimulus indeed for the economy.
                                 ______
                                 
      By Mr. ENZI:
  S. 1642. A bill to open certain withdrawn land in Big Horn County 
Wyoming, to locatable mineral development for bentonite mining; to the 
Committee on Energy and Natural Resources.
  Mr. ENZI. Mr. President, I ask unanimous consent that the text of the 
bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1642

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

     SECTION 1. OPENING OF CERTAIN WITHDRAWN LAND IN WYOMING TO 
                   LOCATABLE MINERAL DEVELOPMENT FOR BENTONITE 
                   MINING.

       (a) In General.--Notwithstanding any other provision of law 
     and subject to subsection (c), the land described in 
     subsection (b) shall be open to locatable mineral development 
     for bentonite mining.
       (b) Covered Land.--The land referred to in subsection (a) 
     is approximately 40 acres of previously withdrawn land 
     located in Big Horn County, Wyoming, at the sixth principal 
     meridian, T. 56 N., R. 95 W., Sec. 32. E\1/2\E\1/2\SE\1/4\, 
     adjacent to Pit No. 144L covered by State of Wyoming Mining 
     Permit No. 321C.
       (c) Closure.--The Secretary of the Army may close the land 
     opened by subsection (a) at any time if the Secretary 
     determines that the closure of the land is required by reason 
     of a national emergency or for purposes of national defense 
     or security.

                          ____________________