text: SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
  
      (a) Short Title.--This Act may be cited as the ``Select Agent 
  Program and Biosafety Improvement Act of 2008''.
      (b) Table of Contents.--The table of contents for this Act is as 
  follows:
  
  Sec. 1. Short title; table of contents.
  Sec. 2. Findings.
               TITLE I--SELECT AGENT PROGRAM REAUTHORIZATION
  
  Sec. 101. Reauthorization of select agent program.
  Sec. 102. Select agent program review.
  Sec. 103. Revision of the list of biological agents and toxins.
  Sec. 104. Sharing information with trusted state partners.
  Sec. 105. Improvements to inventorying and monitoring of agents.
  Sec. 106. Smallpox definition clarification.
  Sec. 107. Plan for surge in samples of biological agents and toxins.
                      TITLE II--BIOSAFETY IMPROVEMENTS
  
  Sec. 201. Improvement of oversight of biocontainment laboratories.
  Sec. 202. Improvement of training for laboratory personnel.
  Sec. 203. Biological laboratory incident reporting system.
  
  SEC. 2. FINDINGS.
  
      Congress finds the following:
              (1) The Centers for Disease Control and Prevention 
          regulates the possession, use, and transfer of select agents 
          and toxins that have the potential to pose a severe threat to 
          public health and safety.
              (2) The Animal and Plant Health Inspection Service 
          regulates the possession, use, and transfer of select agents 
          and toxins that have the potential to pose a severe threat to 
          animal or plant health, or to animal or plant products.
              (3) As of April 2008, there are 72 select agents and 
          toxins, 13 of which are found naturally in the United States.
              (4) As of April 2008, there are 325 entities registered 
          with the Centers for Disease Control and Prevention to work 
          with select agents and toxins and 75 entities registered with 
          the Animal and Plant Health Inspection Service. There are 9,918 
          individuals approved to work with select agents and toxins 
          through the Centers for Disease Control and Prevention and 
          4,336 through the Animal and Plant Health Inspection Service.
              (5) Biocontainment laboratories are used by scientists to 
          study infectious materials safely and effectively. Laboratory 
          biological research is categorized by the safety level at which 
          it is performed. There are 4 safety levels, termed Biosafety 
          Level (BSL) 1 through 4.
  
               TITLE I--SELECT AGENT PROGRAM REAUTHORIZATION
  
  SEC. 101. REAUTHORIZATION OF SELECT AGENT PROGRAM.
  
      (a) Reauthorization of Select Agent Program.--
              (1) Amendment to the public health service act.--Section 
          351A(m) of the Public Health Service Act (42 U.S.C. 262a(m)) is 
          amended by striking ``2002 through 2007'' and inserting ``2009 
          through 2013''.
              (2) Amendment to the agricultural bioterrorism protection 
          act of 2002.--Section 212(m) of the Agricultural Bioterrorism 
          Protection Act of 2002 (7 U.S.C. 8401(m)) is amended by 
          striking ``2002 through 2007'' and inserting ``2009 through 
          2013''.
      (b) Appropriate Training.--
              (1) Amendment to the public health service act.--Section 
          351A(e)(2)(A) of the Public Health Service Act (42 U.S.C. 
          262a(e)(2)(A)) is amended by inserting ``, and appropriate 
          training,'' after ``have a legitimate need''.
              (2) Amendment to the agricultural bioterrorism protection 
          act of 2002.--Section 212(e)(2)(A) of the Agricultural 
          Bioterrorism Protection Act of 2002 (7 U.S.C. 8401(e)(2)(A)) is 
          amended by inserting ``, and appropriate training,'' after 
          ``have a legitimate need''.
      (c) Covered Agencies.--
              (1) Amendment to the public health service act.--Section 
          351A(h)(2)(A) (42 U.S.C. 262a(h)(2)(A)) of the Public Health 
          Service Act is amended by inserting ``the Department of 
          Homeland Security,'' after ``the Department of Agriculture,''.
              (2) Amendment to the agricultural bioterrorism protection 
          act of 2002.--Section 212(h)(2)(A) of the Agricultural 
          Bioterrorism Protection Act of 2002 (7 U.S.C. 8401(h)(2)(A)) is 
          amended by inserting ``the Department of Homeland Security,'' 
          after ``the Department of Agriculture,''.
  
  SEC. 102. SELECT AGENT PROGRAM REVIEW.
  
      (a) In General.--The Secretary of Health and Human Services, in 
  consultation with the Secretary of Agriculture, shall enter into a 
  contract with the National Academy of Sciences to conduct a review of 
  the select agent program under section 351A of the Public Health 
  Service Act (42 U.S.C. 262a) and section 212 of the Agricultural 
  Bioterrorism Protection Act of 2002 (7 U.S.C. 8401). Such review shall 
  focus on--
              (1) the extent to which the program has enhanced 
          biosecurity and biosafety in the United States;
              (2) the effects of the program on--
                      (A) international scientific collaboration; and
                      (B) scientific advances in the United States; and
              (3) other issues as requested by the Secretary of Health 
          and Human Services and the Secretary of Agriculture.
      (b) Report; Recommendations.--Not later than 240 days after the 
  date of enactment of this Act, the National Academy of Sciences shall 
  submit a report to the Secretary of Health and Human Services, the 
  Secretary of Agriculture, the Committee on Health, Education, Labor, 
  and Pensions of the Senate, the Committee on Energy and Commerce of the 
  House of Representatives, and other congressional committees of 
  relevant interest, on the results of the review conducted under 
  subsection (a). Such report shall include recommendations for improving 
  the structure of the select agent program for--
              (1) enhancing the biosecurity and biosafety of the United 
          States;
              (2) eliminating or reducing adverse effects of the program, 
          if any, on--
                      (A) international scientific collaboration; and
                      (B) scientific advances in the United States; and
              (3) other issues as requested by the Secretary of Health 
          and Human Services and the Secretary of Agriculture.
  
  SEC. 103. REVISION OF THE LIST OF BIOLOGICAL AGENTS AND TOXINS.
  
      (a) Amendment to the Public Health Service Act.--Section 
  351A(a)(1)(B)(i) of the Public Health Service Act (42 U.S.C. 
  262a(a)(1)(B)(i)) is amended--
              (1) in subclause (III), by striking ``; and'' and inserting 
          a semicolon;
              (2) by redesignating subclause (IV) as subclause (VII); and
              (3) by inserting after subclause (III) the following:
                                      ``(IV) whether the agent or toxin 
                                  is endemic to the United States, as 
                                  defined by the Secretary;
                                      ``(V) information available from 
                                  biological risk assessments conducted 
                                  by the Department of Homeland Security;
                                      ``(VI) newly discovered agents of 
                                  disease, including genetically modified 
                                  organisms or agents created 
                                  synthetically; and''.
      (b) Amendment to the Agricultural Bioterrorism Protection Act of 
  2002.--Section 212(a)(1)(B)(i) of the Agricultural Bioterrorism 
  Protection Act of 2002 (7 U.S.C. 8401(a)(1)(B)(i)) is amended--
              (1) in subclause (III), by striking ``; and'' and inserting 
          a semicolon;
              (2) by redesignating subclause (IV) as subclause (VII); and
              (3) by inserting after subclause (III) the following:
                                      ``(IV) whether the agent or toxin 
                                  is endemic to the United States, as 
                                  defined by the Secretary;
                                      ``(V) information available from 
                                  biological risk assessments conducted 
                                  by the Department of Homeland Security;
                                      ``(VI) newly discovered agents of 
                                  disease, including genetically modified 
                                  organisms or agents created 
                                  synthetically; and''.
      (c) Rule of Construction.--The amendments made by subsections (a) 
  and (b) shall not be construed to preclude the listing of a biological 
  agent or toxin that is endemic to the United States.
  
  SEC. 104. SHARING INFORMATION WITH TRUSTED STATE PARTNERS.
  
      (a) Amendment to the Public Health Service Act.--Section 351A(h)(5) 
  of the Public Health Service Act (42 U.S.C. 262a(h)(5)) is amended--
              (1) in subparagraph (A), by striking ``; or'' and inserting 
          a semicolon;
              (2) in subparagraph (B), by striking the period and 
          inserting ``; or''; and
              (3) by inserting at the end the following:
                      ``(C) to withhold information regarding a State 
                  that will assist with the State's emergency 
                  preparedness planning from the health director (or 
                  equivalent State official) of such State, if such State 
                  has in place a law to protect against the further 
                  release of such information as determined by the 
                  Secretary.''.
      (b) Amendment to the Agricultural Bioterrorism Protection Act of 
  2002.--Section 212(h)(5) of the Agricultural Bioterrorism Protection 
  Act of 2002 (7 U.S.C. 8401(h)(5)) is amended--
              (1) in subparagraph (A), by striking ``; or'' and inserting 
          a semicolon;
              (2) in subparagraph (B), by striking the period and 
          inserting ``; or''; and
              (3) by inserting at the end the following:
                      ``(C) to withhold information regarding a State 
                  that will assist with the State's emergency 
                  preparedness planning from an elected or appointed 
                  senior State agricultural official or equivalent State 
                  official (such as a State veterinarian or a State plant 
                  health regulatory official) of such State, if such 
                  State has in place a law to protect against the further 
                  release of such information as determined by the 
                  Secretary.''.
  
  SEC. 105. IMPROVEMENTS TO INVENTORYING AND MONITORING OF AGENTS.
  
      (a) Improved Method to Inventory and Monitor Listed Biological 
  Agents.--Not later than 180 days after enactment of this Act, the 
  Secretary of Health and Human Services, in coordination with the 
  Secretary of Agriculture, and in consultation with individuals with 
  appropriate scientific expertise, shall issue guidance on inventorying 
  and monitoring the biological agents listed under section 351A(a)(1) of 
  the Public Health Service Act (42 U.S.C. 262a(a)(1)) and the biological 
  agents listed under section 212(a)(1) of the Agricultural Bioterrorism 
  Protection Act of 2002 (7 U.S.C. 8401(a)(1)).
      (b) Considerations.--In issuing the guidance under subsection (a), 
  the Secretaries shall consider--
              (1) the effectiveness of measures to inventory and monitor 
          listed biological agents that can propagate relative to the 
          burden of these measures on laboratory personnel;
              (2) qualitative and quantitative control procedures for 
          such listed agents, rather than only quantitative control 
          procedures; and
              (3) in what situations registered persons are required to 
          keep inventory records.
  
  SEC. 106. SMALLPOX DEFINITION CLARIFICATION.
  
      Not later than 90 days after the date of enactment of this Act, the 
  Attorney General, in coordination with the Secretary of Health and 
  Human Services, shall issue public guidance regarding how the Attorney 
  General interprets the scope of the statutory definition of ``variola 
  virus'' in section 175c of title 18, United States Code.
  
  SEC. 107. PLAN FOR SURGE IN SAMPLES OF BIOLOGICAL AGENTS AND TOXINS.
  
      The Secretary of Health and Human Services, in coordination with 
  the Secretary of Agriculture and State officials, shall develop and 
  disseminate guidelines for how laboratories and laboratory personnel 
  that do not regularly test for listed agents and toxins (as such terms 
  are defined in section 351A of the Public Health Service Act (42 U.S.C. 
  262a) and section 212 of the Agricultural Bioterrorism Protection Act 
  of 2002 (7 U.S.C. 8401)) may be rapidly accessed and utilized during 
  emergencies in which laboratories and laboratory personnel that 
  regularly test for such agents and toxins are overwhelmed by a surge of 
  samples of such listed agents and toxins.
  
                      TITLE II--BIOSAFETY IMPROVEMENTS
  
  SEC. 201. IMPROVEMENT OF OVERSIGHT OF BIOCONTAINMENT LABORATORIES.
  
      (a) Definition.--For purposes of this section, the term ``high 
  containment biological laboratory'' means a laboratory that has 
  Biosafety Level 3 or Biosafety Level 4 facilities, as defined by the 
  Secretary of Health and Human Services and the Secretary of 
  Agriculture.
      (b) Evaluation.--The Secretary of Health and Human Services, in 
  coordination with the Secretary of Agriculture, and in consultation 
  with the Secretary of Defense and the Secretary of Homeland Security 
  (referred to in this section as the ``Secretaries'') shall, either 
  directly or through a contract, evaluate national needs of, and 
  oversight of, high containment biological laboratories.
      (c) Considerations.--In conducting the evaluation under subsection 
  (b), the Secretaries shall consider--
              (1) whether the construction of high containment biological 
          laboratories that are in existence or planned as of the date of 
          enactment of this Act, is likely to provide sufficient capacity 
          for the needs of Government biodefense and infectious disease 
          research;
              (2) how laboratory capacity and lessons learned can be best 
          shared across the biodefense and infectious disease research 
          communities, domestically and internationally;
              (3) whether guidance on laboratory infrastructure, 
          commissioning, operation, and maintenance of such laboratories 
          is adequate, and if such guidance is found to be inadequate, 
          how to improve and streamline such guidance; and
              (4) ways to improve and streamline the training of the 
          personnel of such laboratories, including recommendations 
          regarding the minimum standards for laboratory biosafety and 
          biosecurity training under section 202.
      (d) Report to Congress.--Not later than 240 days after the date of 
  enactment of this Act, the Secretary of Health and Human Services shall 
  submit to Congress a report on the findings and recommendations from 
  the evaluation under this section.
  
  SEC. 202. IMPROVEMENT OF TRAINING FOR LABORATORY PERSONNEL.
  
      (a) Definition.--For purposes of this section, the term ``high 
  containment biological laboratory'' means a laboratory that has 
  Biosafety Level 3 or Biosafety Level 4 facilities, as defined by the 
  Secretary of Health and Human Services and the Secretary of 
  Agriculture.
      (b) Development of Minimum Standards.--The Secretary of Health and 
  Human Services, acting through the Director of the Centers for Disease 
  Control and Prevention and the Director of the National Institutes of 
  Health, and in coordination with the Secretary of Agriculture and 
  scientific experts representing appropriate professional groups and 
  international health organizations, shall develop minimum standards for 
  laboratory biosafety and biosecurity training for relevant personnel of 
  high containment biological laboratories. In developing such standards, 
  the Secretary of Health and Human Services shall consider existing 
  laboratory guidelines and training modules.
      (c) Requirement for Approval.--A person may not register with the 
  Secretary of Health and Human Services or the Secretary of Agriculture 
  for the possession, use, or transfer of listed agents in accordance 
  with section 351A of the Public Health Service Act (42 U.S.C. 262a) and 
  section 212 of the Agricultural Bioterrorism Protection Act of 2002 (7 
  U.S.C. 8401) unless the person provides to its appropriate personnel 
  biosafety and biosecurity training that meets the minimum standards 
  under subsection (b) in addition to any other requirements determined 
  appropriate by the Secretary of Health and Human Services or the 
  Secretary of Agriculture.
      (d) Dissemination.--The Secretary of Health and Human Services, in 
  coordination with the Secretary of Agriculture, may disseminate the 
  minimum standards under subsection (b) for voluntary use, such as when 
  use is not required under subsection (b), in laboratories and academic 
  programs in the United States and in other countries.
  
  SEC. 203. BIOLOGICAL LABORATORY INCIDENT REPORTING SYSTEM.
  
      (a) In General.--The Secretary of Health and Human Services, in 
  coordination with the Secretary of Agriculture, (referred to in this 
  section as the ``Secretaries'') shall establish an integrated 
  Biological Laboratory Incident Reporting System through which personnel 
  of biological laboratories may voluntarily report biosafety or 
  biosecurity incidents of concern and the Secretaries may identify 
  trends in such incidents and protocols for biosafety or biosecurity 
  improvements. In developing such reporting system, the Secretaries 
  shall consider options for integrating existing voluntary and required 
  reporting mechanisms.
      (b) Functions.--In implementing the reporting system under 
  subsection (a), the Secretaries shall enter into a contract with a 
  public or private entity that does not regulate biological laboratories 
  to administer the reporting system. Such entity shall--
              (1) receive and process incident reports;
              (2) analyze, interpret incident data, and identify incident 
          trends;
              (3) issue alert messages within an appropriate time period;
              (4) disseminate reports and other appropriate information, 
          which shall not include facility-specific information;
              (5) not have authority to direct corrective action or to 
          initiate enforcement action;
              (6) ensure anonymity of individuals reporting to the 
          system, to the extent permitted by law; and
              (7) conduct other activities as requested by the 
          Secretaries.
target: Select Agent Program and Biosafety Improvement Act of 2008 - Amends the Public Health Service Act and the Agricultural Bioterrorism Protection Act of 2002 to reauthorize appropriations for the Select Agent Program, which lists and controls biological agents and toxins that have the potential to pose a severe threat to public health and safety. Requires appropriate training of individuals handling or using such agents and toxins.
  
  Includes the Department of Homeland Security (DHS) among the federal agencies limited in the disclosure of information related to listed agents or toxins.
  
  Requires the Secretary of Health and Human Services to contract with the National Academy of Sciences to review and make recommendations for improving the Select Agent Program.
  
  Sets forth additional factors that the Secretary must consider in determining whether to list an agent or toxin, including whether the agent or toxin is endemic to the United States.
  
  Requires the Secretary to issue guidance on inventorying and monitoring listed biological agents.
  
  Directs the Attorney General to issue guidance regarding the scope of the statutory definition of "variola virus."
  
  Requires the Secretary to: (1) develop guidelines for how laboratories and laboratory personnel that do not regularly test for listed agents and toxins may be rapidly accessed and utilized during emergencies; and (2) evaluate national needs of, and oversight of, high containment biological laboratories.
  
  Provides for the development of minimum standards for laboratory biosafety and biosecurity training for relevant personnel of high containment biological laboratories.
  
  Requires the Secretary to establish a Biological Laboratory Incident Reporting System.
feat_title: A bill to reauthorize the Select Agent Program by amending the Public Health Service Act and the Agricultural Bioterrorism Protection Act of 2002 and to improve oversight of high containment laboratories.